April Through June 2013

April through June 2013

Updated Warnings—Current Drugs Fraudulent Versions of Botox: The FDA is alerting healthcare practitioners and the public that fraudulent versions of Botox that are not approved by the FDA are Codeine Sulfate – Warning: The FDA has issued a being sold to U.S. medical practices. The outer carton is Black Box Warning to the labeling for codeine sulfate oral counterfeit, while the vial inside is labeled as a foreign solution. There is a risk of respiratory depression and version of Botox—which is not FDA-approved for sale in death in children receiving this product after certain the United States. These products are being sold by surgeries—tonsillectomy and/or adenoidectomy. (5/9/13) unlicensed suppliers who are not part of the legitimate US supply chain. The FDA cannot confirm that the Compounding Shop: Lack of Sterility Assurance of manufacture, quality, storage, and handling of these Drug Products: The FDA is alerting healthcare products follow US standards. These fraudulent products providers, hospital supply managers, and pharmacists that are considered unsafe and should not be used. the FDA’s preliminary findings of practices at The The company selling the fraudulent versions of Botox goes Compounding Shop of St. Petersburg, Fla., raise concerns by the names “Online Botox Pharmacy,” about a lack of sterility assurance for sterile drugs “Onlinebotox.com,” and “Onlinebotox.” At the time this produced at and distributed from this site; therefore, these alert was issued, the company did not appear to be selling products should not be administered to patients. If a drug its products over the internet—instead, the company has product marketed as sterile has microbial contamination, it been using “blast faxes” to solicit sales from medical potentially places patients at risk of serious infection. practices, typically selling products at prices below those of The FDA has advised the firm that it is in the best interest FDA-approved products. As is the case with many of public health to take action to remove all sterile products companies that sell fraudulent products, Online Botox from the market. The Compounding Shop has informed Pharmacy uses a US return address when sending packages the FDA that it is recalling sterile products and is in the to medical practices, even though the products are from process of notifying customers. foreign sources. Medications purchased from foreign or The FDA is basing this warning on a recent inspection of unlicensed sources may be misbranded, adulterated, The Compounding Shop. The investigators observed poor counterfeit, contaminated, improperly stored and sterile production practices that raise concerns about a lack transported, ineffective, and/or unsafe. Medical practices of sterility assurance of The Compounding Shop’s sterile that purchase and administer illegal and unapproved drug products. medications from foreign sources are putting patients’ Healthcare providers and hospital staff should immediately health at risk, as patients may not be getting proper check their medical supplies, quarantine any sterile treatment. products from The Compounding Shop, not administer FDA-approved Botox for injection (100 units/vial), them to patients, and await further instructions from the manufactured by Allergan, displays the active ingredient as company regarding the recalled products. Patients who “OnabotulinumtoxinA” on the outer carton and vial. have received any product produced by The Compounding Currently, there is no indication that Allergan’s FDA- Shop and have concerns should contact their healthcare approved version is at risk, and this product should be provider. (5/8/13) considered safe and effective for its intended and approved uses. Fiorinal/Codeine #3—Warning: The FDA is alerting Suspect fraudulent products can be identified as follows: healthcare providers of the risk of respiratory depression the outer carton displays the active ingredient as and death in children related to use of Fiorinal/Codeine #3 “Botulinum Toxin Type A” OR (codeine phosphate/aspirin/ caffeine/butalbital). Such the lot numbers and expiration dates on the outer carton adverse reactions follow tonsillectomies and and accompanying vial do not match adenoidectomies. The manufacturer Watson must include Thus far, the following examples have been confirmed as a Black Box Warning on labeling/package inserts. (May fraudulent Botox. Products with any of these lot numbers 2013) and expiration dates should be considered suspect. www.AmericanHealthCare.com

Example 1 Example 2 • Talk to your healthcare professional about any risk factors or LOT # EXP DATE LOT # EXP DATE concerns you may have with human immune globulin C3016 C3 C3060 C3 products. 10-2014 01-2015 (carton) (carton) • Contact your healthcare professional if you develop any signs C3121 C3 (vial) 04-2015 C3121 C3 (vial) 04-2015 or symptoms of thrombosis during or after receiving human immune globulin. Signs or symptoms of thrombosis may The FDA is asking the public to report suspect Botox include: products obtained from Online Botox Pharmacy or other o pain and/or swelling of an arm or leg with warmth over questionable sources: the affected area a) Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989 o discoloration of an arm or leg b) Report to OCI at o unexplained shortness of breath www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm1, or c) email to [email protected] o chest pain or discomfort that worsens on deep breathing (4/26/13) o unexplained rapid pulse o chest pain

o numbness or weakness on one side of the body Warning – Human Immune Globulin Products: Healthcare professionals should be aware of the risk for The FDA is requiring manufacturers to add information on thrombosis with human immune globulin products and thrombosis to the current boxed warning in the labels of all ensure appropriate patient selection and monitoring. intravenous human immune globulin products and to add a • Discuss with your patients the risk of thrombosis associated boxed warning to the labels of all subcutaneous and with these products. intramuscular human immune globulin products to • Carefully consider risk factors when selecting patients for highlight the risk of thrombosis and to add information on treatment with human immune globulin products. its mitigation. A retrospective analysis of data from a large • Monitor patients carefully for signs and symptoms of health claims-related database, as well as continued thrombosis both at the time of infusion and after infusion postmarketing adverse event reports of thrombosis, have and encourage patients to report any signs or symptoms. strengthened the evidence for an association between the • Report adverse events involving human immune globulin products to the FDA MedWatch program. use of intravenous, subcutaneous, and intramuscular (6/10/13) human immune globulin products and the risk of thrombosis. This information necessitates a boxed Kadcyla and Potential Medication Errors: The FDA warning for the entire class of products. notified healthcare professionals that the use of the Human immune globulin products are used in a variety of incorrect nonproprietary name for the breast cancer drug conditions, both on and off-label, by healthcare Kadcyla (ado-trastuzumab emtansine) in some medication- professionals who may not be aware of the thrombosis risk related electronic systems poses a risk of mix-up with and measures that could be taken to mitigate this risk. Herceptin (trastuzumab) and may result in medication Although all human immune globulin products already errors. The dosing and treatment schedules for Kadcyla contain some information related to the risk of thrombosis and Herceptin, another breast cancer drug, are quite in the current WARNINGS and PRECAUTIONS sections of different; so confusion between these products could lead their labels, the FDA recognizes that the communication of to dosing errors and potential harm to patients. The FDA- this risk and its mitigation are not standardized. The FDA approved nonproprietary name for Kadcyla, ado- proposes that for thrombosis a more prominent placement trastuzumab emtansine, should be used; however, some of risk information and a uniform approach for third-party publications, compendia references, health communicating the risk and its possible mitigation will information systems (e.g., electronic health record systems help to reduce the occurrence of these serious adverse and systems used for pharmacy prescription processing, events: • Thrombosis may occur regardless of the route of wholesaler ordering, pharmacy ordering, etc.), and sites on administration. the Internet are incorrectly using the United States • Risk factors include: advanced age, prolonged Adopted Name (USAN), which is “trastuzumab emtansine,” immobilization, hypercoagulable conditions, history of and omitting the “ado” prefix and hyphen. Use of this venous or arterial thrombosis, use of estrogens, indwelling truncated version of Kadcyla’s nonproprietary name may central vascular catheters, hyperviscosity and cardiovascular cause confusion with Herceptin (trastuzumab). (5/6/13) risk factors. • Thrombosis may occur in the absence of known risk factors. Potiga Warning: The FDA is warning the public that the • For patients at risk of thrombosis, administer at the anti-seizure medication Potiga (ezogabine) can cause blue minimum concentration available and at the minimum rate of infusion practicable. skin discoloration and eye abnormalities characterized by • Ensure adequate hydration in patients before pigment changes in the retina. The FDA does not currently administration. know if these changes are reversible and is working with • Monitor for signs and symptoms of thrombosis and assess the manufacturer to gather and evaluate all available blood viscosity in patients at risk for hyperviscosity. information to better understand these events. The FDA Patients should be aware of this risk and discuss this risk will update the public when more information is available. with their healthcare professionals. Potiga is approved as adjunctive (added on to other anti- • Be aware that thrombosis is associated with human immune seizure medications) treatment of partial-onset seizures in globulin products. adult patients 18 years and older. The skin discoloration in the reported cases appeared as blue pigmentation,

For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 2 predominantly on or around the lips or in the nail beds of observed in the vials. The FDA has received reports of the fingers or toes; but more widespread involvement of adverse events, including skin and soft tissue abscesses. To the face and legs has also been reported. Scleral and date, the FDA is not aware of any cases of meningitis conjunctival discoloration, on the white of the eye and associated with Main Street’s preservative free inside eyelids, has been observed as well. The skin methylprednisolone acetate for injection. (6/7/13) discoloration generally occurred after four years of treatment with Potiga, but has appeared sooner in some Tradjenta & Jentadueto—Pancreatitis Risk: Manu- patients. In some cases, retinal abnormalities have been facturers of Tradjenta (linagliptin) and Jentadueto observed in the absence of skin discoloration. (linagliptin and metformin) are updating prescribing All patients taking Potiga should have a baseline eye exam information for these drugs under FDA approval. Updates and periodic eye exams that should include visual acuity include: testing and dilated fundus photography and may include • There have been reports of patients on linagliptin fluorescein angiograms (FA), ocular coherence tomography developing acute or fatal pancreatitis. Physicians (OCT), perimetry, and electroretinograms (ERG). Patients should be checking for pancreatitis symptoms during who are taking Potiga and develop any changes in your drug treatment. vision or any discoloration of your skin—including of your • It is not known if patients with a history of lips and nail beds—should contact their healthcare pancreatitis are at a greater risk to develop the professional right away. Patients should not stop taking condition while on these drugs. Potiga without talking to their healthcare professional. • Healthcare providers should be informing patients of Stopping such treatment suddenly can cause serious and the possible risks associated with taking these life-threatening medical problems such as recurrence of medications. seizure. (4/26/13) (6/18/13)

Pradaxa Warning: A warning has been added to Valproate Anti-Seizure Products—Contraindicated Pradaxa (dabigatran etexilate mesylate) per the FDA. The for Pregnant Women: indication for Pradaxa is to lessen instances of stroke and valproate sodium (Depacon) systemic embolism for patients with nonvalvular atrial divalproex sodium (e.g., Depakote and Depakote ER) valproic acid (Depakene and Stavzor) fibrillation. Discontinuing Pradaxa places patients at an and their generics increased risk of thrombotic events, and another The FDA is advising healthcare professionals and women anticoagulant should be considered—unless the reason for that the anti-seizure medication valproate sodium and taking Pradaxa does not concern pathological bleeding. related products, valproic acid and divalproex sodium, are (4/25/13) contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Based Samsca (tolvaptan) and Possible Liver Injury: The on information from a recent study, there is evidence that FDA has determined that the drug Samsca (tolvaptan) these medications can cause decreased IQ scores in should not be used for longer than 30 days and should not children whose mothers took them while pregnant. be used in patients with underlying liver disease because it Stronger warnings about use during pregnancy will be can cause liver injury, potentially requiring liver transplant added to the drug labels, and valproate’s pregnancy or causing death. Samsca is used to treat low sodium levels category for migraine use will be changed from “D” (the in the blood. An increased risk of liver injury was observed potential benefit of the drug in pregnant women may be in recent large clinical trials evaluating Samsca for a new acceptable despite its potential risks) to “X” (the risk of use use in patients with autosomal dominant polycystic kidney in pregnant women clearly outweighs any possible benefit disease (ADPKD). The FDA has worked with the of the drug). Valproate products will remain in pregnancy manufacturer to revise the Samsca drug label, including category D for treating epilepsy and manic episodes removal of the indication for use in patients with cirrhosis, associated with bipolar disorder. (5/6/13) a condition that involves scarring of the liver due to injury or long-term disease. Use of Samsca in patients with underlying liver disease, including cirrhosis, should be Recalls/Suspensions avoided because the ability to recover from liver injury may Any adverse events that may be related to the use of these products should be be impaired. (4/30/13) reported to the FDA's MedWatch Adverse Event Reporting Program (contact information located at the end of the bulletin).

Adverse Reactions with Steroid Injections: The FDA has identified bacterial and fungal growth in samples from Recall of Atriphen: The nutraceutical company, two unopened vials of preservative-free (PF) Xymogen, (Orlando, FL), and the FDA are notifying methylprednisolone acetate (MPA) 80 mg/mL, 10mL vials consumers and health professionals of the recall of form Main Street Family Pharmacy. The microbial growth Atriphen, a product sold for the support of healthy joint was seen in samples from two separate lots (batches). function, because it contains the undeclared allergens, soy, Additional samples and lots of PF MPA are still under and milk. evaluation, as well as other sterile products produced by Xymogen learned that Atriphen might contain the two Main Street. The FDA, in partnership with the CDC, is allergens and immediately discontinued sale of the product working to identify the exact species of fungus and bacteria For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 3 and had a third-party laboratory test the product to regarding this recall may contact Lowlite by phone at 888- confirm the presence of the allergens. 323-7788 or 407-673-2222 from the hours of 9:00am- People who have an allergy or severe sensitivity to either 6:00pm Eastern Daylight Time, Monday through Friday; or milk or soy run the risk of serious or life-threatening by e-mail: [email protected]. Patients who allergic reaction if they consume this product. Although have received any product furnished by Lowlite and have there have been no reported allergic reactions or any concerns should contact their healthcare provider. adverse events in connection with the product to date, (5/30/13) consumers are urged to return this product for a full refund. More information is available at Recall of EZ Breathe Atomizers: A Medical Device www.xymogen.com. For comments or inquiries, Recall was issued due to a manufacturing defect which consumers may email [email protected]. (5/9/13) could result in the washer ("Plate A") becoming dislodged from the EZ Breathe Atomizer. If this occurs, users may Recall of Rugby Enteric-coated Aspirin 81mg accidentally swallow the washer or choke on it, which can Tablets: Advance Pharmaceutical, Inc. announced that it lead to serious adverse health consequences or death. is conducting a voluntary nationwide recall to the user level The EZ Breathe Atomizer is a device that is intended to of an over-the-counter drug product – Enteric-coated spray liquid medication in aerosol form into the air that a Aspirin tablets 81mg under the “Rugby” label (lot 13A026). person will breathe. Devices were distributed between The manufacturer initiated the recall after receiving a August 2012 and April 2013. The EZ Breathe Atomizer is complaint about a bottle labeled as containing enteric- manufactured by Health & Life Co., LTD and sold to coated aspirin tablets 81mg but actually holding Nephron Pharmaceuticals Corporation. Nephron acetaminophen 500mg tablets. Pharmaceuticals Corporation distributes the EZ Breathe Consumers may be inadvertently taking 500mg of Atomizer for sale and use in the Asthmanefrin Starter Kit. acetaminophen instead of 81mg of enteric-coated aspirin. The EZ Breathe Atomizer was also sold by Nephron Acetaminophen may cause severe liver damage to those Pharmaceuticals Corporation as an individual device in a who a) take other drugs containing acetaminophen, b) take carton labeled EZ Breathe Atomizer, Model #EZ-100. 3 or more alcoholic drinks every day, or c) have liver Customers should stop using any EZ Breathe Atomizer disease. The directions for the aspirin instruct patients to units contained in the Asthmanefrin Starter Kits with the take 4-8 tablets every 4 hours, but not more than 48 tablets affected lot numbers and also those that were sold in 24 hours. Consumers who take 48 tablets daily of the individually. Refer to the Recall Notice [FDA site] for a defective product may be ingesting up to 24,000mg of link to the affected lot and serial numbers. (6/3/13) acetaminophen – about six times the maximum recommended daily dose of acetaminophen (4,000mg). Recall of FreeStyle InsuLinx Blood Glucose Meters: The affected lot of Enteric-coated Aspirin Tablets 81mg is Abbott initiated a voluntary recall of FreeStyle lnsulinx 13A026, with expiration date of 01-2015. The lot was Blood Glucose Meters in the United States. At extremely manufactured and packaged by Advance Pharmaceutical high blood glucose levels of 1024 mg/dL and above, the Inc. under the label of Rugby Laboratories. FreeStyle InsuLinx Blood Glucose Meter will display and Consumers who have the affected lot should immediately store in memory an incorrect test result that is 1024 mg/dL discontinue its use and return it to the pharmacy or store below the measured result. Blood glucose levels at 1024 where it was purchased. Consumers should contact their mg/dL and above are very rare; however, if high blood physician or healthcare provider if they have experienced glucose levels of 1024 mg/dL and above occur, they are a any problems that may be related to taking or using this serious health risk that requires immediate medical product. (6/19/13) attention. The FreeStyle InsuLinx Blood Glucose Meter measures Recall of Sterile Compounded Products: Lowlite sugar (glucose) in blood drawn from the fingertips of Investments d/b/a Olympia Pharmacy ("Lowlite") notified people with diabetes to monitor blood sugar levels. On the public of a voluntary multi-state recall of all sterile drug April 15, 2013, Abbott Diabetes Care sent an Urgent products compounded by the pharmacy that have not Product Recall letter to all its affected customers. The reached the expiration date listed on the product. The FreeStyle InsuLinx Blood Glucose Meters were distributed recall is being initiated due to concerns associated with from April 18, 2012 through April 1, 2013. Consumers who prior quality control procedures that impacted sterility are using the FreeStyle InsuLinx Meter should immediately assurance. In the event a sterile product is compromised, take one of the following actions to address this issue with patients are at risk for serious and possible life-threatening your meter: infections. . Access a software update to install on your meter to resolve The recall includes all sterile products that Olympia the issue at www.freestyleinsulinx.com/swupdate. The Pharmacy supplied to patients and offices of licensed software update will allow you to maintain settings and medical professionals with a use by date of 09/25/2013 or historical data on your meter. earlier. Olympia Pharmacy will be notifying customers by . Contact Abbott Diabetes Care Customer Service at 1-866- 723-2697 to expedite return and replacement of your phone, fax, or mail to return the products to the pharmacy. FreeStyle InsuLinx meter at no charge. Replacements are To date, Lowlite has received no reports of injury or illness available, and Abbott will send a meter to you immediately associated with the use of the affected products. upon request. Consumers or healthcare providers with questions (5/20/13) For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 4 to microembolisation in areas where the particles lodge. Recall of LifeScan, Inc. OneTouch Verio IQ Blood Clinical symptoms are not to be expected from these Glucose Meters: The OneTouch Verio IQ Blood Glucose microemboli and Sandoz is not aware of any reports of Meter is an over-the-counter, single-use device intended to related adverse events. be used by a patient outside of a healthcare facility as an Methotrexate is an antimetabolite used in the treatment of aid to monitor the effectiveness of diabetes control neoplastic diseases, severe psoriasis, and rheumatoid measures sugar (glucose) in blood drawn from the arthritis, including polyarticular juvenile rheumatoid fingertips. All OneTouch Verio IQ Blood Glucose Meters arthritis. The lot numbers and expiration dates of the two are being recalled that were distributed from December 14, recalled lots are: CL0996 (expiration date 12/2013) and 2011 through March 7, 2013. CJ4948 (expiration date 05/2013). These lots were At extremely high blood glucose levels of 1024 mg/dL and distributed nationally across the US and to a single foreign above, the OneTouch Verio IQ Meter will turn off instead of country (Poland). displaying the message “EXTREME HIGH GLUCOSE In the event that a patient experiences an adverse reaction above 600 mg/dL” as intended. When turned back on, the or quality problem involving this product, they should meter enters the “Set-Up” mode and requires the user to immediately contact their healthcare professional as well as confirm the date and time settings before being able to test Sandoz to report the finding. The Sandoz Drug again. If the glucose level is still measuring 1024 mg/dL or Information Direct Line is open at 800-525-2492, 24 above when testing, the meter will shut down again. hours/day, seven days a week, or reports can be made via Therefore, if the OneTouch Verio IQ Meter unexpectedly email at [email protected]. (5/21/13) turns off and enters set-up mode after turning it back on, blood glucose may be extremely high, and you should call Recall of NuVision [Dallas Facility] Pharmacy your healthcare professional. Call LifeScan Customer Products: The FDA is alerting healthcare providers of Service at 1-800-717-0276 for support. (4/23/13) concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Recall of Compounded Prescription Therapies By Pharmacy of Dallas, Texas. The FDA is basing this Pentec Health Inc.: Pentec Health, Inc. initiated a expanded alert on a recent inspection of the NuVision limited, voluntary recall of in-date nutritional prescriptions Dallas facility, during which FDA investigators observed for renal patients due to lack of sterility assurance poor sterile production practices that raise concerns about associated with one of its laminar flow hoods used in a lack of sterility assurance of the company’s sterile drug compounding. Pentec Health has received no reports of products. The agency is not aware of any additional injury or illness associated with any of the prescriptions adverse event reports associated with other sterile products subject to this recall; however, because patients are at from NuVision. increased risk of infection in the event a sterile product is In April 2013, NuVision recalled methylcobalamin compromised, the pharmacy is recalling any unused injection and lyophilized injection products due to a lack of product whose beyond-use date has not passed. sterility assurance and concerns associated with the quality These renal therapies were supplied to renal dialysis control processes identified during the FDA inspection. centers and directly to patients. Pentec Health is directly The FDA received adverse event reports of fever, flu-like notifying each dialysis center and in-home dialysis patient symptoms, and soreness at the injection site associated of the recall. Prescriptions for a total of 163 patients are with the methylcobalamin injection product that was included in the scope of this recall. The recall covers renal previously recalled. therapies that were compounded in this hood on or before For all sterile products from NuVision, the FDA May 2, 2013. Sterility tests associated with the recommends that healthcare providers and other compounding hood involved, as well as testing of finished healthcare professionals, including hospital staff, products made in the hood, have shown sterility. immediately check their medical supplies for NuVision Consumers or healthcare providers with questions sterile products, quarantine those products, and not regarding this recall may contact Pentec Health by phone administer them to patients. Patients who were at 800-223-4376, prompt 7, or e-mail at administered any sterile drug products produced and [email protected], Monday through Friday, distributed by NuVision and who have concerns should between 9:00 am and 8:00 pm EDT. Patients who have contact their healthcare provider. (5/18/13) received any prescriptions prepared by Pentec Health and have concerns should contact their healthcare provider. Recall of Warfarin 2mg Tablets: Zydus Pharma- (5/17/13) ceuticals USA Inc. is voluntarily recalling one lot of Warfarin 2mg tablets, Lot #MM5767, expiration date June Recall of Methotrexate Sodium, USP Injectable 2014 to the retail level. Four tablets of Warfarin 2 mg Vials by Sandoz US: Sandoz is conducting a voluntary tablets, Lot MM5767, have been found to be oversized in nationwide recall to the hospital/user level of two lots of its one product complaint. Ingestion of a greater than methotrexate sodium, USP, 25 mg/mL, 40 mL vial intended dose of this medication, could lead to an injectable product in the US, due to the discovery of increased pharmacological effect. As a result, patients particulate matter in vials during routine quality would be more likely to develop bleeding as an adverse examination of retention samples at the manufacturer. reaction and in some patients that bleeding into a critical Parenteral injection of drug from the affected lots can lead organ (mostly the central nervous system) could be fatal. For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 5 The risk of bleeding is increased if overdosing is repeated recommended for people younger than 18 years. Breo continuously on a daily basis. Ellipta may cause serious side effects, including increased The product is used as prophylaxis and treatment of venous risks of pneumonia and bone fractures. The most common thrombosis and its extension, pulmonary embolism (PE), side effects reported by patients using Breo Ellipta included prophylaxis and treatment of thromboembolic inflammation of the nasal passage (nasopharyngitis), upper complications associated with atrial fibrillation (AF) respiratory tract infection, headache, and oral candidiasis and/or cardiac valve replacement, and reduction in the risk (thrush). (5/10/13) of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic Dabrafenib & Trametinib: The FDA approved embolization after myocardial infarction. Product is dabrafenib (TAFINLAR capsule, GlaxoSmithKline, LLC) packaged in HDPE Bottle of 1000's count, which may have and trametinib (MEKINIST tablet, GlaxoSmithKline, LLC) been dispensed to patients in smaller bottles. The product for the treatment of patients with unresectable or can be identified by its NDC #6838205310. The product metastatic melanoma with BRAF V600E or V600K was distributed nationwide in the United States to mutation as detected by an FDA-approved test. wholesalers/distributors, retailers, and mail-order Dabrafenib is not indicated for the treatment of patients providers from November 2012 to December 2012. with wild-type BRAF melanoma because of the potential Consumers should contact their physician or healthcare risk of tumor promotion. The FDA also approved the provider if they have experienced any problems that may THxID BRAF assay (bioMerieux, Inc.) for detection of be related to taking or using this particular lot of Warfarin BRAF V600E mutations. The most frequent (≥20% 2 mg tablets. Anyone with an existing inventory of this incidence) adverse reactions from dabrafenib are particular Lot MM5767 of Warfarin 2 mg tablets should hyperkeratosis, headache, pyrexia, arthralgia, papilloma, stop use and distribution; quarantine the recalled lots alopecia, and palmar-plantar erythrodysesthesia syndrome. immediately; and call INMAR at 1-800-967-5952 between Serious adverse reactions were development of new the hours of 7am to 4pm CST, Monday through Friday, to primary skin cancers (cutaneous squamous cell carcinoma, arrange for their return. In case patients have tablets of new primary melanomas, and keratoacanthomas), febrile this lot of product, make sure all the tablets are of same drug reactions requiring hospitalization, hyperglycemia, size; and, if unsure, patients should consult their and uveitis/iritis. Dabrafenib is approved with a dispensing pharmacy. (6/12/13) Medication Guide to inform patients of these serious potential risks. The recommended dose and schedule for Approved Drugs dabrafenib is 150 mg orally twice daily, until disease progression or unacceptable toxicity. Dabrafenib should be Please access www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm taken at least one hour before or two hours after a meal. for in-depth drug approval information. Confirmation of the presence of BRAF V600E is needed prior to initiation of dabrafenib because of the risks of Breo Ellipta for COPD: The FDA approved Breo Ellipta potential risk of tumor promotion in patients with BRAF (fluticasone furoate and vilanterol inhalation powder) for wild-type melanoma. the long-term, once-daily, maintenance treatment of air- Trametinib is not indicated for treatment of patients who flow obstruction in patients with chronic obstructive pul- have received prior BRAF inhibitor therapy. The FDA also monary disease (COPD), including chronic bronchitis approved the THxID BRAF assay (bioMerieux, Inc.) for and/or emphysema. It is also approved to reduce exacer- detection of BRAF V600E and V600K mutations. The bations of COPD in patients with a history of exacerba- most frequent (≥ 20% incidence) adverse reactions from tions. trametinib were rash, diarrhea, and lymphedema. Serious COPD is a serious lung disease that worsens over time. adverse drug reactions occurring in patients taking Symptoms can include chest tightness, chronic cough and trametinib included cardiomyopathy, retinal pigment excessive phlegm. Cigarette smoking is the leading cause epithelial detachment, retinal vein occlusion, interstitial of COPD—according to the National Heart, Lung, and lung disease, and serious skin toxicity. The recommended Blood Institute—and COPD is the third-leading cause of dose and schedule for trametinib is 2 mg orally once daily, death in the United States. continued until disease progression or unacceptable Breo Ellipta works by decreasing inflammation in the lungs toxicity. Trametinib should be taken at least one hour and helping the muscles around the airways of the lungs before or two hours after a meal. (5/29/13) stay relaxed to increase airflow and reduce exacerbations in patients with COPD. The drug carries a boxed warning that Diclegis for Pregnant Women Experiencing LABAs increase the risk of asthma-related death. The safe- Nausea and Vomiting: The FDA approved Diclegis ty and efficacy of Breo Ellipta in patients with asthma have (doxylamine succinate and pyridoxine hydrochloride) to not been established, and it is not approved for the treat- treat pregnant women experiencing nausea and vomiting. ment of asthma. Diclegis is a delayed-release tablet intended for women The FDA approved Breo Ellipta with a patient medication who have not adequately responded to conservative guide that includes instructions for use and information management of nausea and vomiting during pregnancy, about the potential risks of taking the drug. Breo Ellipta such as dietary and lifestyle modifications. These should not be used as a rescue therapy to treat sudden modifications include eating several small meals instead of breathing problems (acute bronchospasm) and is not three large meals, eating bland foods that are low in fat and For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 6 easy to digest, and avoiding smells that can trigger nausea. demonstrated to be similar to plasma in terms of the ability (4/8/13) to stop acute major bleeding. (4/29/13)

Karbinal ER: The FDA approved the extended-release Liptruzet for Hyperlipidemia: The drug Liptruzet version of carbinoxamine maleate—brand name Karbinal (ezetimibe/atorvastatin) was approved by the FDA to use ER. It is an oral suspension (4mb/5mL) indicated for the in combination with diet for control of LDL cholesterol symptomatic treatment of: levels. (5/3/13)  Seasonal and perennial allergic rhinitis  Vasomotor rhinitis Namenda XR: Nameda XR (memantine hydrochloride),  Allergic conjunctivitis due to inhalant allergens and in a 28mg dosage to be taken once each day, has been foods released for sale in the US. The medication may be  Mild, uncomplicated allergic skin manifestations of prescribed with or without the addition of other urticaria and angioedema acetylcholinesterase inhibitors for the treatment of  Dermatographism Alzheimer’s disease. In trials, a small percentage of  As therapy for anaphylactic reactions adjunctive to patients reported side effects of headache, diarrhea, and/or epinephrine and other standard measures after the dizziness. (6/13/13) acute manifestations have been controlled  Amelioration of the severity of allergic reactions to Nymalize for Brain Hemorrhaging: The FDA blood or plasma approved Nymalize, a new nimodipine oral solution, to This product is appropriately labeled for use in ages 2 or treat patients experiencing symptoms resulting from older. It is manufactured by Tris Pharma. (3/28/13) ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was available only as Kcentra for Anticoagulation Reversal: The FDA ap- a liquid-filled gel capsule. proved Kcentra—prothrombin complex concentrate (hu- Subarachnoid hemorrhage is serious, life-threatening man)—for the urgent reversal of vitamin K antagonist bleeding that occurs in the subarachnoid space – the area (VKA) anticoagulation in adults with acute major bleeding. between the brain and the thin tissues that cover the brain. Plasma is the only other product approved for this use in Nimodipine is a medication given in a critical care setting the United States. to treat neurologic complications from subarachnoid Patients receiving chronic anticoagulation therapy with hemorrhage. Over the years, the FDA has received reports warfarin and other VKA anticoagulants to prevent blood of serious and sometimes fatal consequences from clotting in conditions such as atrial fibrillation or the pres- intravenous (IV) injection of the liquid contents of oral ence of an artificial heart valve sometimes develop acute nimodipine capsules. IV administration of nimodipine bleeding. Like plasma, Kcentra is used in conjunction with meant for oral use can result in death, cardiac arrest, severe the administration of vitamin K to reverse the anticoagula- decreases in blood pressure and other heart-related tion effect and stop the bleeding. Unlike plasma, Kcentra complications. In August 2010, the agency reminded does not require blood group typing or thawing, so it can be healthcare professionals about the risks of IV administered more quickly than frozen plasma. administration of nimodipine from oral capsules and in “The FDA’s approval of this new product gives physi- 2006 a Boxed Warning was added to the drug to warn cians a choice when deciding how to treat patients re- against such use. This new oral formulation may help quiring urgent reversal of VKA anticoagulation," said reduce potentially fatal medication errors. (5/14/13) Karen Midthun, M.D., director, Center for Biologics Evaluation and Research, FDA. “Kcentra is adminis- Prolensa from Bausch + Lomb: To treat postoperative tered in a significantly lower volume than plasma at inflammation and reduce ocular pain in patients who have recommended doses, providing an alternative for those undergone cataract surgery, a new drug—generic name patients who may not tolerate the volume of plasma bromfenac, brand name Prolensa—was approved by the required to reverse VKA anticoagulation.” FDA. (4/8/13) Kcentra is associated with the occurrence of blood clots when used as indicated, and carries a boxed warning Rixubis: The FDA approved Rixubus (generic name regarding the risk of blood clots. The warning also explains coagulation factor IX recombinant) for use in perioperative that patients receiving Kcentra should be monitored for management, to control and prevent bleeding episodes, signs and symptoms of thromboembolic events, as both and as routine therapy to prevent and reduce the frequency fatal and non-fatal arterial and venous thromboembolic of bleeding episodes in patients with hemophilia B who are complications have been reported in clinical trials and post 16 years of age or older. (6/27/13) marketing surveillance. Kcentra is made from the pooled plasma of healthy donors. It is processed in a way to Simbrinza and Intraocular Pressure: The FDA minimize the risk of transmitting viral and other diseases. approved Simbrinza (brinzolamide/brimonidine tartrate The FDA approval of Kcentra was based on a study of 216 ophthalmic suspension) 1%/0.2%―a fixed combination of patients who had been receiving VKA anticoagulation and a carbonic anhydrase inhibitor and an alpha 2 adrenergic who had acute major bleeding along with a clotting test receptor agonist indicated for the reduction of elevated value indicative of anticoagulant use. Kcentra was intraocular pressure in patients with open-angle glaucoma or ocular hypertension. (May 2013) For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 7 diabetes in adults can now be filled at US pharmacies. Xgeva for Giant Cell Tumor of the Bone: The FDA These new options are: expanded the approved use of Xgeva (denosumab) to treat NESINA (alogliptin) adults and some adolescents with giant cell tumor of the KAZANO (alogliptin and metformin HCl) bone (GCTB), a rare and usually non-cancerous tumor. OSENI (alogliptin and pioglitazone) GCTB generally occurs in adults between the ages of 20 (6/18/13) and 40 years. In most cases, GCTB does not spread to other parts of the body but destroys normal bone as it grows – causing pain, limited range of motion, and bone New Generics fractures. Rarely, GCTB can transform into a cancerous tumor and spread to the lungs. Xgeva is a monoclonal antibody that binds to RANKL, a Generic Zomig and Zomig-ZMT Tablets: The FDA protein essential for maintenance of healthy bone. RANKL approved two forms (2 strengths each) of generic is also present in GCTB. Xgeva is intended for patients zolmitriptan for the treatment of migraines. (5/15/13) whose GCTB cannot be surgically removed (unresectable) or when surgery is likely to result in severe morbidity, such Generic Zovirax Ointment: Acyclovir 5% ointment, a as loss of limbs or joint removal. It should only be used in generic therapeutically equivalent to the brand Zovirax, adolescents whose bones have matured. was approved by the FDA under the manufacturer Mylan. Common side effects included joint pain (arthralgia), This product is for the management of initial genital herpes headache, nausea, fatigue, back pain, and extremity pain. and in limited non–life-threatening mucocutaneous herpes The most common serious side effects were osteonecrosis simplex virus infections in immunocompromised patients. (areas of dead bone) of the jaw and osteomyelitis (4/3/13) (inflammation or infection of the bone). Women of reproductive potential should use highly effective New Indications contraception while taking Xgeva because of potential fetal harm. Xgeva was approved in 2010 to prevent fractures when Actemra: The company Genetech, Inc. (member of the cancer has spread to the bones. It is marketed by Amgen, Roche Group) received approval from the FDA to add the based in Thousand Oaks, Calif. (6/13/13) treatment of polyarticular juvenile idiopathic arthritis in patients 2 years and older to other indications on the label Xofigo for Advanced Prostate Cancer: The FDA of Actemra (tocilizumab) injection. (4/29/13) approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration- Amitiza: The FDA has approved Amitiza, generic name resistant prostate cancer that has spread to bones but not lubiprostone, to treat opioid-induced constipation for to other organs. It is intended for men whose cancer has patients experiencing chronic, non-cancer related pain. spread after receiving medical or surgical therapy to lower Amitiza was previously indicated to treat chronic, testosterone. idiopathic constipation in adult patients and for irritable Prostate cancer forms in a gland in the male reproductive bowel syndrome with constipation in women who are 18 system found below the bladder and in front of the rectum. years of age and older. (5/30/13) The male sex hormone testosterone stimulates the prostate tumors to grow. According to the National Cancer Erlotinib: The FDA approved erlotinib [Tarceva, Astellas Institute, an estimated 238,590 men will be diagnosed with Pharma Inc.] for the first-line treatment of metastatic non- prostate cancer and 29,720 will die from the disease in small cell lung cancer (NSCLC) patients whose tumors have 2013. epidermal growth factor receptor (EGFR) exon 19 deletions In August 2012, the FDA approved Xtandi to treat men or exon 21 (L858R) substitution mutations. This indication with metastatic castration-resistant prostate cancer that for erlotinib is being approved concurrently with the cobas has spread or recurred, even with medical or surgical EGFR Mutation Test, a companion diagnostic test for therapy to minimize testosterone. Xtandi is approved for patient selection. (5/14/13) patients who have previously been treated with the chemotherapy drug docetaxel. Ilaris: The FDA approved another indication for Ilaris The most common side effects reported during clinical (canakinumab) by Novartis. This drug may be prescribed trials in men receiving Xofigo were nausea; diarrhea; for— vomiting; and swelling of the leg, ankle, or foot. The most Cryopyrin-Associated Periodic Syndromes (CAPS), in common abnormalities detected during blood testing adults and children 4 years of age and older including included low levels of red blood cells (anemia), • Familial Cold Autoinflammatory Syndrome (FCAS) lymphocytes (lymphocytopenia), white blood cells • Muckle-Wells Syndrome (MWS) (leukopenia), platelets (thrombocytopenia), and infection- Active Systemic Juvenile Idiopathic Arthritis (SJIA) in fighting white blood cells (neutropenia). (5/15/13) patients aged 2 years and older (5/9/13) Nesina, Kazano, and Oseni: Prescriptions for select medications by Takeda Pharmaceuticals to treat type 2 For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 8 Simponi: The FDA approved a new use for Simponi release properties. Such manipulation causes the drug to (golimumab) injection to treat adults with moderate to be released more rapidly, which increases the risk of severe ulcerative colitis. Simponi works by blocking tumor serious adverse events, including overdose and death. In necrosis factor (TNF), which plays an important role in April 2010, the FDA approved a reformulated version of causing abnormal inflammatory and immune responses. OxyContin, which was designed to be more difficult to Previously approved to treat rheumatoid arthritis, psoriatic manipulate for purposes of misuse or abuse. Purdue arthritis, and ankylosing spondylitis (arthritis affecting the stopped shipping original OxyContin to pharmacies in joints in the spine and the pelvis), Simponi is now August 2010. approved to treat adults with moderate to severe ulcerative The FDA has determined that the reformulated product has colitis that is resistant (refractory) to prior treatment or abuse-deterrent properties. The tablet is more difficult to requires continuous steroid therapy. crush, break, or dissolve. It also forms a viscous hydrogel Ulcerative colitis is a chronic disease that affects about and cannot be easily prepared for injection. The agency 620,000 Americans. It causes inflammation and ulcers in has determined that the physical and chemical properties the inner lining of the large intestine and is one of two of the reformulated product are expected to make the main forms of chronic inflammatory bowel disease. The product difficult to inject and to reduce abuse via snorting; inflammation can lead to abdominal discomfort, however, abuse of OxyContin by these routes, as well as the gastrointestinal bleeding, production of pus and diarrhea. oral route, is still possible. The reformulated product also The most common side effects in patients treated with may reduce incidents of therapeutic misuse, such as Simponi are upper respiratory infection and redness at the crushing the product to sprinkle it onto food or to site of injection. Patients treated with Simponi are at administer it through a gastric tube. When the FDA finds increased risk of developing serious infections, invasive that a new formulation has abuse deterrent properties, the fungal infections, reactivation of Hepatitis B infection, agency has the authority to require generics to have abuse- lymphoma, heart failure, nervous system disorders and deterrent properties also. (4/16/13) allergic reactions. (5/15/13) RELATED ARTICLE Neura Therapeutik Response to FDA Concerns Sustiva: The FDA approved the inclusion of patients 3 (ABUSE-DETERRENT FORMULATIONS): A pain specialty months of age and older (minimum weight 3.5 kilograms) company—Neura Therapeutik LLC—has responded to for Bristol-Myers Squibb’s Sustiva (efavirenz) in the concerns documented by the FDA about the misuse of combination treatment of human immunodeficiency virus opioids such as OxyContin (oxycodone). It will be focusing type 1 (HIV-1) infection. (5/3/13) on the development of formulations that will counteract common methods of abuse. (4/17/13)

Revised Labeling/ Indication Change for Samsca: The FDA approved a Prescribing Information change in the labeling of Samsca (tolvaptan). The indications and usage section now reads: SAMSCA is a selective vasopressin V2-receptor Important Changes to the Atripla Labeling: The antagonist indicated for the treatment of clinically FDA approved changes to the label for Atripla (efavirenz/ significant hypervolemic and euvolemic hyponatremia emtricitabine/tenofovir disoproxil fumarate) tablets. [serum sodium <125 mEq/L or less marked (4/17/13) hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients Abuse-Deterrent Labeling for Reformulated with heart failure and Syndrome of Inappropriate OxyContin: The FDA approved updated labeling for Antidiuretic Hormone (SIADH). Important Purdue Pharma L.P.’s reformulated OxyContin (oxycodone limitations: hydrochloride controlled-release) tablets. The new labeling • Patients requiring intervention to raise serum indicates that the product has physical and chemical sodium urgently to prevent or to treat serious properties that are expected to make abuse via injection neurological symptoms should not be treated difficult and to reduce abuse via the intranasal route with SAMSCA. (snorting). • It has not been established that SAMSCA provides Additionally, because original OxyContin provides the a symptomatic benefit to patients. same therapeutic benefits as reformulated OxyContin but (4/9/13) poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original Label Information for Zolpidem-containing OxyContin no longer outweigh its risks and that original Products: The FDA is notifying the public that the FDA OxyContin was withdrawn from sale for reasons of safety has approved label changes specifying new dosing or effectiveness. Accordingly, the agency will not accept or recommendations for zolpidem products [Ambien, Ambien approve any abbreviated new drug applications (generics) CR, and Edluar], which are widely prescribed sleep that rely upon the approval of original OxyContin. medications. The FDA has approved these changes The FDA approved the original formulation of OxyContin because of the known risk of next-morning impairment in December 1995. The product was abused, often with these drugs. (5/14/13) following manipulation intended to defeat its extended- For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 9 Drug Safety Labeling Changes: The MedWatch Safety words “BEST BY”, followed by the code T012415 Labeling Changes posting includes products with safety sequentially through T053115, then followed by a letter. labeling changes to sections BOXED WARNINGS, All of these letter designations are included in this recall CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, for the lot codes listed above. ADVERSE REACTIONS and/or PATIENT PACKAGE The product was also sold at Harris Teeter stores from INSERT. The following drugs had modifications to the April 19 until May 7, 2013, under the product name BOXED WARNINGS, CONTRAINDICATIONS and/or Harris Teeter Organic Antioxidant Berry Blend, 10 oz. WARNINGS sections in the month of March: bag [UPC 0 72036 70463 4] with lot codes of T041613E Brilinta (ticagrelor) or T041613C and a “BEST BY” code of 101614. (6/5/13) Carafate (sucralfate) Wellbutrin, Wellbutrin SR (bupropion hydrochloride) Anaprox, Anaprox DS (naproxen sodium tablets) Emergency Contraceptive—No Prescription: The Avastin (bevacizumab) FDA announced it has approved the use of Plan B One- Clozaril (clozapine) Step (levonorgestrel) as a nonprescription product for all Coly-Mycin M Parenteral Solution (colistimethate sodium, USP) women of child-bearing potential. This action complies EC-Naprosyn (naproxen delayed-release tablets) Erbitux (cetuximab) with the April 5, 2013 order of the United States District Firmagon (degarelix for injection) Court in New York to make levonorgestrel-containing Geodon (ziprasidone HCl) emergency contraceptives available as an over-the- Geodon (ziprasidone mesylate) counter (OTC) product without age or point-of-sale Humalog (insulin lispro [rDNA origin] injection) Humalog Mix 50/50 (50% insulin lispro protamine suspension/50% restrictions. insulin lispro [rDNA origin] injection) Plan B One-Step is an emergency contraceptive intended Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% to reduce the chance of pregnancy following unprotected insulin lispro [rDNA origin] injection) sexual intercourse or a known or suspected INOmax (nitric oxide) for Inhalation Levemir (insulin detemir [rDNA origin] injection) contraceptive failure (e.g., condom). Plan B One-Step is Lopressor (metoprolol tartrate) Tablets a single-dose pill (1.5 mg tablet) that is effective in Lopressor (metoprolol tartrate) injection decreasing the chance of pregnancy and should be taken Maxipime (cefepime hydrochloride, USP for injection) as soon as possible within three days after unprotected Merrem I.V. (meropenem for injection) Naglazyme (galsulfase) sex. The product contains higher levels of a hormone Naprosyn (naproxen tablets) found in some types of daily use oral hormonal NovoLog (insulin aspart [rDNA origin] injection) contraceptive pills and works in a similar way to these NovoLog Mix 50/50 (50% insulin aspart protamine suspension and 50% contraceptive pills by stopping ovulation and therefore insulin aspart [rDNA origin] injection) NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% preventing pregnancy. insulin aspart [rDNA origin] injection) Plan B One-Step will not stop a pregnancy when a Remicade (infliximab) woman is already pregnant, and there is no medical Rythmol (propafenone HCl) evidence that the product will harm a developing fetus. Silvadene (silver sulfadiazine) Tegretol (carbamazepine) and The product will not protect a woman from HIV/AIDS or Tegretol-XR (carbamazepine extended-release) other sexually transmitted diseases. It is important that Vectibix (panitumumab) young women who are sexually active see a healthcare Arthrotec (diclofenac sodium/misoprostol) provider for routine checkups. The healthcare provider Carbatrol (carbamazepine) Cerebyx (fosphenytoin sodium) should counsel the patient about and test them for Dilantin-125 (phenytoin) sexually transmitted diseases, discuss effective methods Dilantin (phenytoin sodium, USP) of routine birth control, and answer any other questions Toradol (ketorolac tromethamine) the patient may have. Visicol (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Some women taking Plan B One-Step have reported (4/15/13) experiencing the following side effects: nausea, vomiting, stomach pain, headache, dizziness and breast

tenderness. These are similar to the side effects of Miscellaneous regular prescription-only birth control pills. (6/20/13)

Hepatitis A Outbreak–Frozen Fruit Connection?: Townsend Farms, Inc. of Fairview, Oregon, recalled certain lots of its frozen Organic Antioxidant Blend on June 3, 2013, because it has the potential to be contaminated with Hepatitis A virus. No other Townsend Farms products, frozen or fresh, are covered by this voluntary recall or linked to the illness outbreak at this time. The product was sold at Costco warehouse stores under the product name Townsend Farms Organic Antioxidant Blend, 3 lb. bag [UPC 0 78414 404448]. The recalled codes are located on the back of the package with the

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FUTURE DRUG RELEASES LISTED ON NEXT PAGE.

GENERIC DRUGS PIPELINE

† indicates the medication has been approved but may or may not be available

* indicates the medication is anticipated to be filed with the FDA at the listed date Estimated Generic Name Brand Name Brand Manufacturer Indication(s) / Use Approval/ Market Date alendronate/ Fosamax Plus D Merck Osteoporosis JUNE 2013 cholecalciferol mesalamine Asacol Warner Chilcott Ulcerative colitis, proctitis JUL 2013 imiglucerase injection Cerezyme Genzyme Gaucher disease AUG 2013 temozolomide Temodar Schering Cancer AUG 2013 lovastatin/niacin Advicor Abbott Cholesterol SEP 2013 mycophenolate injec- CellCept Roche Palo Kidney, heart or liver transplant SEP 2013 tion lidocaine Lidoderm Endo Pharmaceuticals Pain SEP 2013 niacin ER tablet Niaspan Abbott Cholesterol SEP 2013 valganciclovir Valcyte Roche Cytomegalovirus SEP 2013 hydromorphone hy- Exalgo Mallinckrodt Moderate to severe pain NOV 2013 drochloride duloxetine hydrochlo- Anxiety, depression, fibromyalgia, neurop- Cymbalta Lilly DEC 2013 ride athy fluocinonide Vanos Medicis Plaque-type psoriasis DEC 2013 estradiol Vivelle-Dot Novartis Symptoms of menopause DEC 2013 transdermal patch capecitabine Xeloda Roche Breast cancer, colorectal cancer DEC 2014 flunisolide Aerospan Acton Asthma 2013 tolterodine ER Detrol LA Pfizer Overactive bladder JAN 2014 ethinyl estradiol/ Loestrin 24 Fe Warner Chilcott Birth control pill JAN 2014 norethindrone telmisartan Micardis Boehringer Ingelheim High blood pressure JAN 2014 telmisartan/ Micardis HCT Boehringer Ingelheim High blood pressure JAN 2014 hydrochlorothiazide sirolimus tablet Rapamune Wyeth Organ rejection prevention JAN 2014 fenofibric acid Trilipix Abbott Cholesterol JAN 2014 doxercalciferol Hectorol Sanofi-Aventis Hyperparathyroidism FEB 2014 moxifloxacin Avelox Bayer Antibiotic MAR 2014 raloxifene Evista Lilly Osteoporosis, breast cancer risk reduction MAR 2014 sirolimus oral solution Rapamune Wyeth Organ rejection prevention MAR 2014 sevelamer carbonate Renvela Genzyme Chronic kidney disease MAR 2014 tablet ezetimibe/simvastatin Vytorin Merck Cholesterol MAR 2014 prednisolone Orapred ODT Shionogi Pharma Asthma, atopic dermatitis, allergic rhinitis APR 2014 nelfinavir mesylate Viracept ViiV Healthcare Antiretroviral APR 2014 eszopiclone Lunesta Sepracor Insomnia MAY 2014 Gastroesophageal reflux esomeprazole Nexium AstraZeneca MAY 2014 disease (GERD), ulcers argatroban 100mg/mL Acova Pfizer Thrombosis JUN 2014 risedronate Actonel Procter & Gamble Osteoporosis JUN 2014 tazarotene Tazorac Gel Allergan Acne vulgaris, plaque psoriasis JUN 2014 mometasone furoate Nasonex Schering Allergies JUL 2014 bimatoprost Lumigan Allergan Glaucoma, ocular hypertension AUG 2014 adefovir dipivoxil Hepsera Gilead Chronic hepatitis B SEP 2014 sevelamer hydrochlo- Renagel Genzyme Chronic kidney disease SEP 2014 ride sevelamer carbonate Renvela Genzyme Chronic kidney disease SEP 2014 suspension amlodipine/valsartan Exforge Novartis High blood pressure OCT 2014 amlodipine/valsartan/ Exforge HCT Novartis High blood pressure OCT 2014 hydrochlorothiazide tobramycin Tobi Novartis Cystic fibrosis OCT 2014 travoprost Travatan Z Travatan Z Glaucoma, ocular hypertension DEC 2014 memantine tablet Namenda Forest Alzheimer’s disease JAN 2015 ritonavir Norvir Abbott Antiviral JAN 2015 trandolapril/ Tarka Abbott High blood pressure FEB 2015 verapamil

efavirenz Sustiva Bristol-Myers Squibb Antiviral MAR 2015 colesevelam tablet Welchol Daiichi Sankyo Cholesterol MAR 2015 omega-3-acid Lovaza GlaxoSmithKline Cholesterol 1Q2015 ethyl esters aripiprazole Abilify Otsuka Psychiatric conditions APR 2015 Chemo-associated nausea & vomiting; pre- aprepitant Emend Merck APR 2015 vention of post-op nausea & vomiting oxybutynin Oxytrol Watson Overactive bladder APR 2015 linezolid tablet Zyvox Pfizer Bacterial infections MAY 2015 epinephrine Epipen Mylan Anaphylactic reactions JUN 2015 gemifloxacin tablet Factive Cornerstone Antibiotic JUN 2015 aspirin/dipyridamole Aggrenox Boehringer Ingelheim Stroke prevention JUL 2015 imatinib Gleevec Novartis Cancer JUL 2015 testosterone Androgel 1% Solvay Hormone replacement AUG 2015 glatiramer acetate Copaxone Teva Multiple sclerosis SEP 2015 guanfacine ER tablets Intuniv Actavis ADHD SEP 2015 fenofibrate Fenoglide Santarus Cholesterol OCT 2015 dutasteride Avodart GlaxoSmithKline Benign prostatic hyperplasia NOV 2015 almotriptan Axert Ortho-McNeil-Janssen Migraine NOV 2015 dutasteride/tamsulosin Jalyn GlaxoSmithKline Benign prostatic hypertrophy NOV 2015 celecoxib Celebrex Pfizer Osteoarthritis, pain DEC 2015 norgestimate/ethinyl Ortho Tri-Cyclen Lo Ortho Mcneil Janssen Birth control pill DEC 2015 estradiol olopatadine Pataday Alcon Allergic conjunctivitis DEC 2015 olopatadine Patanol Alcon Allergic conjunctivitis DEC 2015 metformin hydrochlo- Glumetza Santarus Type 2 diabetes mellitus FEB 2016 ride ER abacavir/lamivudine Epzicom GlaxoSmithKline Antiviral MAR 2016 armodafinil Nuvigil Teva Sleep disorders JUN 2016 rosuvastatin Crestor AstraZeneca Cholesterol JUL 2016 darifenacin Enablex Novartis Overactive bladder AUG 2016 olmesartan Benicar Daiichi Sankyo High blood pressure OCT 2016 olmesartan/ hydro- Benicar HCT Daiichi Sankyo High blood pressure OCT 2016 chlorothiazide quetiapine ER tablet Seroquel XR AstraZeneca Antipsychotic NOV 2016 lopinavir/ritonavir Kaletra Abbott Antiviral DEC 2016 cinacalcet tablet Sensipar Amgen Hyperparathyroidism, hypercalcemia DEC 2016 ezetimibe Zetia Merck Cholesterol DEC 2016 atomoxetine Strattera Lilly Attention-deficit/hyperactivity disorder MAY 2017 atazanavir Reyataz Bristol-Myers Squibb Antiretroviral JUL 2017 caspofungin acetate Cancidas Merck Fungal infections SEP 2017 tadalafil Adcirca Synthon Pulmonary arterial hypertension NOV 2017 tenofovir Viread Gilead Antiviral JAN 2018 repaglinide Prandin Novo Nordisk Type 2 diabetes JUN 2018 fentanyl buccal tablet Fentora Cephalon Breakthrough cancer pain OCT 2018 vardenafil Levitra Teva Erectile dysfunction OCT 2018 Diabetic peripheral neuropathy, pregabalin Lyrica Pfizer postherpetic neuralgia, seizure, fibromyal- DEC 2018 gia Gastroesophageal reflux rabeprazole Aciphex Eisai approved† disease (GERD), ulcers nedocromil ophthalmic Alocril Allergan Allergies approved† rosiglitazone Avandia GlaxoSmithKline Type 2 diabetes approved† sodium phosphate monobasic monohydrate & sodium phos- Visicol Salix Pharmaceuticals Colon cleansing prior to colonoscopy approved† phate dibasic anhydrous dolasetron Anzemet Sanofi Aventis Nausea/vomiting uncertain efavirenz/ emtricitabine/ Atripla Gilead Antiviral uncertain tenofovir metformin/ Avandamet GlaxoSmithKline Type 2 diabetes uncertain rosiglitazone rosiglitazone/ Avandaryl GlaxoSmithKline Type 2 diabetes uncertain glimepiride valsartan Diovan Novartis High blood pressure uncertain

rivastigmine solution Exelon Novartis Alzheimer’s disease/Parkinson’s disease uncertain dexmethylphenidate Focalin XR Novartis Attention-deficit/hyperactivity disorder uncertain ER capsule fluvastatin ER tablet Lescol XL Novartis Cholesterol uncertain trazodone ER tablet Oleptro Angelini Depression uncertain oxycodone ER tablet OxyContin Purdue Pharma Pain uncertain (old formulation) BRAND DRUGS PIPELINE TBA = to be announced

† indicates the medication has been approved but may or may not be available

* indicates the medication is anticipated to be filed with the FDA at the listed date Estimated FDA filing/ Drug Name Manufacturer Indication(s) / Use Approval/ Market Date JUN – NOV TBA (suvorexant) Merck Insomnia 2013 TBA (naloxegol) AstraZeneca, Nektar Opioid-induced constipation (OIC) 3Q2013 Decrease birthing time to vaginal delivery for women who have an Misopress (misoprostol) Ferring AUG 2013 unfavorable cervix Brintellix (vortioxetine) Lundbeck, Takeda Major depressive disorder OCT 2013 TBA (bazedoxifene/ Menopausal symptoms and prevention of postmenopausal osteo- Ligand, Pfizer OCT 2013 conjugated estrogens porosis TBA (canagliflozin/ Janssen Type 2 diabetes OCT–DEC 2013 metformin IR) Oralair (grass pollen al- Stallergenes, Sublingual tablet formulation of a freeze dried extract of NOV 2013 lergen immunotherapy) Paladini grass pollen allergens for allergic rhinitis Grazax, Alutard SQ (ALK NOV 2013 – Grass Pollen Tablet, Merck, ALK-Abello Prevention of allergies caused by grass pollen allergen JAN 2014 Phleum pretense) NOV 2013 – Syncria (albiglutide) GlaxoSmithKline Type 2 diabetes JAN 2014 Sanofi Aventis, Zea- Lyxumia (lixisenatide) Type 2 diabetes DEC 2013 land AstraZeneca, Bristol Forxiga (dapagliflozin) Type 2 diabetes 2013 Myers Squibb Hyponatremia associated with heart failure & syndrome of inap- Lixar (lixivaptan) Cornerstone 2013 propriate antidiuretic hormone Luveniq (voclosporin) Lux Biosciences Uveitis 2013 Solpura (liprotamase) Eli Lilly Exocrine pancreatic insufficiency 2013 Stedesa (eslicarbazepine) Sunovion Adjunct therapy for partial-onset seizures 2013 Chelsea Therapeu- Northera (droxidopa) Neurogenic orthostatic hypotension 2Q2013 (filing*) tics AL-60371 Alcon Otitis externa and media with a tympanostomy tube 2013 (filing*) Ideglira (insulin Novo Nordisk Type 2 diabetes mellitus 2013 (filing*) degludec/liraglutide) Kremezin (carbonaceous Mitsubishi Tanabe Chronic kidney disease 2013 (filing*) oral adsorbent) Lixiana (edoxaban) Daiichi Sankyo Stroke prevention in atrial fibrillation 2013 (filing*) GW Pharmaceuticals Sativex (nabiximols) Cancer pain, spasticity in multiple sclerosis (MS) 2013 (filing*) Otsuka TBA (bardoxolone me- Reata, Abbott Diabetic neuropathy, chronic kidney disease 2013 (filing*) thyl) TBA (dulaglutide) Eli Lilly Type 2 diabetes 2013 (filing*) TBA (dutogliptin) Phenomix Type 2 diabetes 2013 (filing*) Major depressive disorder (MDD), Attention deficit hyperactivity TBA (edivoxetine) Eli Lilly 2013 (filing*) disorder (ADHD) TBA (rolapitant) OPKO, Tesaro Prevention of chemo-induced nausea & vomiting 2013 (filing*) Newron, Merck TBA (safinamide) Parkinson’s disease 2013 (filing*) Serono Vanda, Bristol Myers TBA (tasimelteon) Insomnia, sleep disorders, depression 2013 (filing*) Squibb TBA (taspoglutide) Ispen Type 2 diabetes 2013 (filing*) TBA (tavaborole) Anacor Oncyhomycosis 2013 (filing*) SIGA Technologies, TBA (tecovirimat) Smallpox infection 2013 (filing*) ViroPharma

TBA (tedizolid phos- Trius Acute bacterial skin & skin structure infections 2013 (filing*) phate) TBA (umeclidinium) GlaxoSmithKline Chronic obstructive pulmonary disease (COPD), asthma 2013 (filing*) GlaxoSmithKline, TBA (vilanterol) Chronic obstructive pulmonary disease (COPD) 2013 (filing*) theravance Vivageln/A Starpharma Bacterial vaginosis 2013 (filing*) TBA (vorapaxar sulfate) Merck Cardiovascular event prevention in select patients 2013 (filing*) Acute bacterial skin & skin structure infections caused by gram- Zeven (dalbavancin) Durata Therapeutics positive bacteria including MRSA (methicillin resistant Staphylo- 2013 (filing*) coccus aureus) Zydena (udenafil) Warner Chilcott Erectile dysfunction (ED) 2013 (filing*) TBA (palonosetron/ 2013 – 2014 Helsinn, Elsai Chemotherapy-induced nausea & vomiting (CINV) netupitant) (filing*) TBA (ALK Ragweed Tab Merck, ALK-Abello Ragweed allergies, rhinoconjunctivitis JAN 2014 (ambrosia artemisiifolia) Boehringer TBA (empagliflozin) Type 2 diabetes 1Q2014 (filing*) Ingelheim, Eli Lilly TBA (lasmiditan) CoLucid Treatment of migraine 4Q2014 (filing*) Arimenda Adamas, Forest Alzheimer’s dementia 2014 (filing*) (memantine/donepezil) FV-100 Inhibitex Varicella zoster virus infection, Herpes zoster 2014 (filing*) TBA Novartis Heart failure 2014 (filing*) (AHU-377/valsartan) MuDelta: JNJ-27018966 Furiex Diarrhea-predominant irritable bowel syndrome (IBS-D) 2014 (filing*) Regeneron, Sanofi TBA (alirocumab) Cholesterol 2014 (filing*) Aventis Ardea Biosciences, TBA (lesinurad) Hyperuricemia, gout 2014 (filing*) AstraZeneca TBA (mavoglurant) Novartis Fragile X syndrome 2014 (filing*) TBA (obeticholic acid) Intercept Primary biliary cirrhosis, hepatic fibrosis 2014 (filing*) TBA (odanacatib) Merck, Celera Osteoporosis 2014 (filing*) TBA (omarigliptin) Merck Type 2 diabetes mellitus 2014 (filing*) TBA (patiromer) Relypsa Hyperkalemia in patients with chronic kidney disease (CKD) 2014 (filing*) TBA (pimavanserin) Acadia, Biovail Parkinson’s disease (PD) psychosis 2014 (filing*) TBA (preladenant) Merck Parkinson’s disease 2014 (filing*) Dainippon Sumito- TBA (ranirestat) Diabetic peripheral neuropathy 2014 (filing*) mo Pharma, Elsai Eleison, Threshold 2014 -2015 (fil- TBA (glufosfamide) Pancreatic cancer Pharmaceuticals ing*) Isis-ApoIIIRx, Isis- Isis Hypertriglyceridemia 2015 (filing*) 304801 Stedicor (azimilide) Forest Ventricular arrhythmia 2015 (filing*) Cardiovascular disease risk reduction in high risk patients with TBA (aleglitazar) Takeda 2015 (filing*) type 2 diabetes TBA (ozenoxacin) Ferrer Skin & skin structure infections 2015 (filing*) TBA (elagolix) Abbott, Neurocrine Endometriosis 2016 (filing*) Human Genome Abthrax (raxibacumab) Inhalation anthrax approved† Sciences Breo Ellipta (fluticasone GlaxoSmithKline, furoate/vilanterol Chronic obstructive pulmonary disease (COPD) approved† Theravance trifenotate) Fycompa (perampanel) Elsai Adjunct therapy for partial onset seizures approved† Stendra (avanafil) Vivus A PDE5 inhibitor for erectile dysfunction approved† A synthetic surfactant for prevention of respiratory Surfaxin (lucinactant) Discovery Labs approved† distress syndrome in premature infants Beriplex (human 4-factor Urgent reversal of vitamin K-antagonist (warfarin) therapy prothrombin complex CSL, Behring uncertain in patients with acute major bleeding concentrate) Linjeta (insulin, human) Biodel Type 1 or Type 2 diabetes uncertain Pandemrix, Prepandrix H5N1 avian influenza for pre-pandemic use (Prepandrix) GlaxoSmithKline uncertain (H5N1 influenza vaccine) & pandemic use (Pandemrix) Striverdi Respimat Boehringer Asthma, chronic obstructive pulmonary disease uncertain (olodaterol) Ingelheim TBA (cobicistat) Gilead HIV-1 infection uncertain TBA (efinaconazole) Kaken, Valeant Distal lateral subungal onychomycosis uncertain TBA (elvitegravir) Gilead HIV-1 infection in treatment-experienced adults uncertain TBA Yaopon Early stage (stages I-IIA) mycosis fungoides uncertain (mechlorethamine HCL) 15

Diabetes and/or hypertriglyceridemia in those with TBA (metreleptin) Amylin uncertain rare forms of lipodystrophy Vyndaqel (tafamidis FoldRx, Pfizer Transthyretin familial amyloid polyneuropathy uncertain meglumine) BRAND DRUGS PIPELINE — New Formulations TBA = to be announced

† indicates the medication has been approved but may or may not be available

* indicates the medication is anticipated to be filed with the FDA at the listed date Estimated FDA filing/ Drug Name Manufacturer Indication(s) / Use Approval/ Market Date Trokendi XR (topiramate Supernus Epilepsy JUN 2013 ER) TBA (levomilnacipran) Forest Major depressive disorder JUL 2013 Zubsolv (buprenorphine/ Orexo Opioid drug addiction JUL 2013 naloxone) Flu Q-QIV; D-QIV AUG – OCT (quadrivalent inactivated Biologicals Influenza prevention in those >/= 3 years of age 2013 split virion vaccine) MoxDuo IR (mor- QRxPharma, Actavis New oral formulation for moderate to severe acute pain AUG 2013 phine/oxycodone) TBA (diclofenac nano- Iroko Mild to moderate acute pain in adults 4Q2013 formulation) Zecuity (sumatriptan NuPathe Migraine 4Q2013 transdermal) Afrezza (insulin human [rDNA origin] inhalation MannKind Type 1 & Type 2 diabetes SEP 2013 powder) Duodopa Abbott Parkinson’s disease SEP – OCT 2013 (carbidopa/levodopa) Iluvien (fluocinolone acetonide extended re- Alimera, pSivida Diabetic macular edema OCT 2013 lease) TBA (amphetamine Neos Therapeutics Attention deficit hyperactivity disorder OCT 2013 polistirex) Anoro Ellipta GlaxoSmithKline, (umeclidinium bro- Chronic obstructive pulmonary disease DEC 2013 Theravance mide/vilanterol) adenovirus types 4 & 7 Teva Prevention of severe acute respiratory diseases 2013 (live oral vaccines) Contrave (naltrexone HCL/bupropion extend- Orexigen, Takeda Obesity 2013 ed release) Remoxy (oxycodone HCL Pfizer, Pain Thera- Moderate to severe chronic pain 2013 controlled release) peutics Durect Rytary (carbidopa/ levo- Impax Parkinson’s disease 2013 dopa extended-release) TBA (zucapsaicin-cis- Winston Osteoarthritis 2013 capsaicin) Treatment of keratoconus & corneal ectasia Vibex (riboflavin) Avedro 2013 following refractive surgery Zoely (nomegesterol ace- Merck Prevention of pregnancy 2013 tate/17 beta-estradiol) Zohydro (hydrocodone bitartrate extended- Zogenix, Elan Moderate to severe chronic pain 2013 release) CompleoTRT (testos- Trimel Male hypogonadism 2Q2013 (filing*) terone intranasal) TBA (budesonide) Salix Ulcerative colitis (UC) 3Q2013 (filing*) TBA (sufentanil nanotab) AcelRx Post-operative pain 3Q2013 (filing*) Lightlake Therapeu- 3Q2013 – 2014 TBA (naloxone) Binge eating disorder tics (filing*) Ventrus, SLA Anoheal (diltiazem HCL) Pain associated with anal fissure 4Q2013 (filing*) Pharma TBA (ondansetron) RedHill BioPharma Prevention of nausea & vomiting in cancer patients 4Q2013 (filing*)

Ameluz (5- aminolevulinic acid Biofrontera Actinic keratosis 2013 (filing*) nanocolloidal) Bromsite (bromfenac) InSite Vision Pain, swelling, & inflammation associated with ocular surgery 2013 (filing*) Dexasite (dexame- InSite Vision Blepharitis 2013 (filing*) thasone) Duromist (sildenafil) NovaDel Erectile dysfunction 2013 (filing*) Watson, Gedeon Esmya (ulipristal acetate) Anemia associated with uterine leiomyomas 2013 (filing*) Richter Lecette (desogestrel/ethinyl es- Teva Prevention of pregnancy 2013 (filing*) tradiol) Mycova (terbinafine) ApriCus Onychomycosis 2013 (filing*) Natpara (recombinant human parathyroid hor- NPS, Takeda Hypoparathyroidism 2013 (filing*) mone) Octreolin (ocreotide ace- Chiasma, Roche Acromegaly 2013 (filing*) tate) Posidur (Bupivacaine SR) Durect, Hospira Postoperative pain 2013 (filing*) Relistor (methylnaltrexone bro- Salix Opioid-induced constipation (OIC) in chronic pain 2013 (filing*) mide) TBA (dapagliflozin/ AstraZeneca, Bristol Type 2 diabetes 2013 (filing*) metformin) Myers Squibb TBA (dexamethasone) EyeGate Dry eye, uveitis 2013 (filing*) TBA (dexamethasone) Icon Bioscience Treatment of inflammation associated with cataract surgery 2013 (filing*) TBA KemPharm, Mono- Attention deficit hyperactivity disorder 2013 (filing*) (dextroamphetamine) Sol Rx TBA (ethinyl estradi- Agile Therapeutics Prevention of pregnancy 2013 (filing*) ol/levonorgestrel) TBA (etodolac/lidocaine) IL Pharma, Kowa Pain & inflammation 2013 (filing*) Iron deficiency anemia (IDA) associated with inflammatory bowel TBA (ferric iron complex) Shield Therapeutics 2013 (filing*) disease (IBS) Iron deficiency anemia (IDA) associated with inflammatory bowel TBA (ferric trimaltol) Vitra 2013 (filing*) disease (IBS) TBA Shionogi, Sciele Premature ejaculation (PE) 2013 (filing*) (lidocaine/prilocaine) TBA (rifamycin SV Santarus Infectious diarrhea 2013 (filing*) MMX) Tredaptive (niacin Merck Cholesterol 2013 (filing*) ER/laropiprant) Zerenex (ferric citrate) Keryx, Panacor Hyperphosphatemia in end-stage renal disease 2013 (filing*) Prophylaxis of invasive Aspergillus & Candida infections in those Noxafil (posaconazole) Merck FEB 2014 who areseverely immunocompromised Seebri Breezhaler (glycopyrronium bro- Vectura, Novartis Chronic obstructive pulmonary disease 1Q2014 (filing*) mide long-acting) TBA (aclidinium bro- Forest Chronic obstructive pulmonary disease (COPD) 1Q2014 (filing*) mide/formoterol) TBA (omeprazole imme- Secondary prevention of cardio- and cerebro-vascular events and JAN 2014 (fil- diate-release/aspirin Pozen to reduce the risk of gastric ulcers in patients at risk of aspirin in- ing*) delayed-release) duced gastric ulcers Neuropathic pain associated with chemo-induced peripheral neu- Amiket (keta- EpiCept ropathy in patients previously treated with taxane-based chemo- 2014 (filing*) mine/amitriptyline) therapy Androxal (enclomiphene Repros Secondary hypogonadism 2014 (filing*) citrate) Bema LA (buprenorphine BioDelivery, Endo Moderate to severe chronic pain 2014 (filing*) buccal) Impracor (ketoprofen) Imprimis Acute pain 2014 (filing*) TBA (basal insulin ana- Eli Lilly, Boehringer Type 1 and Type 2 diabetes 2014 (filing*) log) Ingelheim TBA (glycopyrronium Novartis Moderate/severe chronic obstructive pulmonary disease 2014 (filing*) bromide/indacaterol) Eli Lilly, Boehringer TBA (insulin peglispro) Type 1 and Type 2 diabetes 2014 (filing*) Ingelheim TBA (olopatadine) Alcon, Novartis Ocular allergy 2014 (filing*)

TBA (pediatric hexava- lent combination vac- Merck Hepatitis B virus (HBV) infection 2014 (filing*) cine) TBA Merck Type 2 diabetes, atherosclerosis 2014 (filing*) (sitagliptin/atorvastatin) Vycavert (hydrocodone/ Acura Moderate to severe pain 2014 (filing*) acetaminophen) Secondary hyperparathyroidism associated with vitamin D insuffi- Replidea (calcifediol) Cytochroma 2015 (filing*) ciency in patients with chronic kidney disease (CKD) Ryzodeg (insulin Novo Nordisk Type 1 & Type 2 diabetes 2016 degludec/insulin aspart) Tresiba (insulin Novo Nordisk Type 1 & Type 2 diabetes 2016 degludec) Adasuve (loxapine) Alexza, Valeant Rapid treatment of agitation in schizophrenia and bipolar disorder approved† Cornerstone Thera- Bethkis (tobramycin) Cystic fibrosis patients with Pseudomonas aeruginosa approved† peutics Fabior (tazarotene) Stiefel Facial acne vulgaris approved† Flublok (influenza vac- Protein Sciences Influenza prevention in adults 18 years of age and older approved† cine) Marqibo (vincristine sul- Talon Acute lymphoblastic leukemia approved† fate) Quartette (levonorgestrel/ Teva Prevention of pregnancy approved† ethinyl estradiol) Sitavig (acyclovir lauriad) BioAlliance Herpes simplex virus-1 infections approved† Ximino (minocycline Ranbaxy Moderate to severe acne approved† extended-release) Alprox-TD; Vitaros Warner Chilcott Erectile dysfunction uncertain (alprostadil) Asacard Flamel, NewHaven Secondary prevention of cardiovascular disease uncertain (acetylsalicylic acid) Aveed (testosterone Endo Male hypogonadism uncertain undecanoate) Bronchitol (mannitol) Pharmaxis Cystic fibrosis uncertain Civanex Winston Osteoarthritis of the knee uncertain (civamide/zucapsaicin) Dyloject Javelin, Hospira Management of acute moderate to severe pain in adults uncertain (cyclodextrin/diclofenac) Epanova (eicosapentaenoic ac- Omthera High triglycerides uncertain id/docosahexaenoic acid) Esomezol (esomeprazole Hanmi Gastric ulcer uncertain strontium) Heplisav (hepatitis B Prevention of hepatitis B virus infection in healthy Dynavax uncertain virus vaccine) adults 18-70 years of age Injectafer (ferric Lutipold Iron deficiency anemia uncertain carboxymaltose) Levadex Map, Nektar, Aller- Migraine uncertain (dihydroergotamine) gan Optaflu Novartis Influenza virus infection prevention in patients >/= 18 years of age uncertain (influenza virus vaccine) Ostora (calcitonin/ re- Tarsa Therapeutics, Osteoporosis uncertain combinant salmon) Unigene Pennsaid (diclofenac Nuvo Research, Osteoarthritis of the knees uncertain sodium viscous solution) Mallinckrodt Probuphine (buprenor- Titan Opioid dependence in adults uncertain phine SR) Sefelsa (gabapentin CR) Depomed, Abbott Moderate to severe vasomotor symptoms due to menopause uncertain TBA (carbinoxamine) Tris Allergies uncertain TBA (cysteamine delayed release/mercaptamine Raptor Nephropathic cystinosis uncertain delayed-release) TBA (ethinyl estradi- Agile Therapeutics Prevention of pregnancy uncertain ol/levonorgestrel) TBA (granisetron sus- AP Pharma Chemotherapy-induced nausea & vomiting uncertain tained-release)

References:

1. Pharmacist’s Letter, New Drugs Approved† by the FDA in 2012, Therapeutic Research Center, 1995-2012, last accessed 12/6/12, http://pharmacistsletter.therapeuticresearch.com/pl/NewDrugs.aspx?cs=&s=PL&pt=20 2. Pharmacist’s Letter, Anticipated Availability of First-Time Generics, Therapeutic Research Center, 3120 W. March Lane, PO Box 8190, Stockton, CA 95208, Copyright © 1995-2012, All rights reserved, last accessed 12/6/12, http://pharmacistsletter.therapeuticresearch.com/pl/ArticleDD.aspx?nidchk=1&cs=&s=PL&dd=251011&pb=&pt=2&fpt=55&m enu=ftg 3. HealthTrans,Generic Pipeline Report, SXC company, 2012, last accessed 11/6/12, http://www.healthtrans.com/Clinical/Clinical_v2/Clinical%20Documents/2012-01-Drug%20Pipeline%20Report.pdf 4. Rx Outlook: Generic Pipeline 2012-2014, SXC Drug Information Services, 2012 SXC Health Solutions, Inc. Volume 6, Issue 1, 1st Quarter 2012 5. Rx Outlook: Generic Pipeline October 2012-2015, SXC Drug Information Services, 2012 SXC Health Solutions, Inc. Volume 6, Issue 4, 4st Quarter 2012 6. Rx Outlook: Non-specialty pipeline – remainder of 2012-2014, SXC Drug Information Services, 2012 SXC Health Solutions, Inc. Volume 6, Issue 5, 4st Quarter 2012 7. Rx Outlook: Non-specialty pipeline – 2013-2016, Catamaran Inc. Drug Intelligence Services, 2013 Catamaran Inc. Volume 7, Is- sue 5, 2nd Quarter 2013 8. Rx Outlook: Generic Pipeline April 2013 to April 2016, Catamaran Inc. Drug Intelligence Services, 2013 Catamaran Inc. Volume 7, Issue 4, 2nd Quarter 2013 9. RxHighlights, SXC Health Solutions, Inc. Volume 5, Issue 7, 8 and 9, August 2012 10. RxHighlights, SXC Health Solutions, Inc. Volume 5, Issue 10, September 2012 11. RxHighlights, Catamaran, Volume 5, Issue 11, October 2012 12. Express Scripts, Medco, Estimated Dates of Possible First-time Generics/Rx-to-OTC Market Entry, June 2012