TrendsRx® June 2009 TrendsRx®Drug Pipeline & News Volume 5, Number 6 Pipeline Highlights: April 27, 2009 – May 29, 2009 and Recent Selected Health Care News Highlights
Selected Generic Product Approvals/Launches1,2* azelastine Dosage Form; Strength Spray, nasal; 125 mcg/spray hydrochloride Approval Date† April 30, 2009 (Astelin®) Anticipated Launch Date‡ TBD Comments The reference brand is used for the treatment of the symptoms of seasonal allergic rhinitis (patients 5 years of age and older) and nonallergic vasomotor rhinitis (patients 12 years of age and older). This product is therapeutically equivalent to its reference brand and will be available from a single generics manufacturer. mycophenolate Dosage Forms; Strengths Tablet, oral; 500 mg mofetil Capsule, oral; 250 mg (Cellcept®) Approval Date† May 4, 2009 Launch Date‡ May 4, 2009 Comments This product is AB-rated and will be available from multiple generics manufacturers.
Recent Product Launches1,2* Savella™ Dosage Form; Strengths Tablet, oral; 12.5 mg, 25 mg, 50 mg and 100 mg (milnacipran) Indication For the management of fibromyalgia Launch Date‡ April 28, 2009 Cypress Bioscience, Inc./Forest Laboratories, Inc. Ryzolt™ (tramadol Dosage Form; Strengths Tablet, oral, extended-release; 100 mg, 200 mg and 300 mg. extended release) Indication For the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time Purdue Pharma Launch Date‡ May 7, 2009
Recent Biologic License Application (BLA) Approvals1,2* Simponi™ Dosage Form; Strength Injection, subcutaneous; 50 mg/0.5 mL in a single dose prefilled SmartJect autoinjector and 50 mg/0.5 mL in a single (golimumab) dose prefilled syringe Indications For the treatment of moderately to severely active rheumatoid arthritis in adults, in combination with methotrexate; active psoriatic arthritis in adults, alone or in combination with methotrexate; and active ankylosing spondylitis in adults Centocor Ortho Approval Date April 24, 2009 Biotech LLC Launch Date‡ April 30, 2009
www.caremark.com Recent New Drug Application (NDA) Approvals1,2* Dysport® Dosage Form; Strengths Injection, intramuscular; 250 units/0.5 mL and 500 units/mL (botulinum toxin Indications For the treatment of cervical dystonia and for the temporary improvement in the appearance of moderate to severe type A) glabellar lines associated with procerus and corrugator muscle activity in adult patients < 65 years of age Approval Date April 30, 2009 ‡ Ipsen Inc./Medicis Launch Date Second and third quarter 2009 Pharmaceutical Comments Ipsen will market Dysport for cervical dystonia with an anticipated launch in the second half of 2009. Corp. Medicis will market Dysport for glabellar lines with an anticipated launch in Q2 2009. Exforge® HCT Dosage Form; Strengths Tablet, oral; 5mg/160mg/12.5mg, 10mg/160mg/12.5mg, 5mg/160mg/25mg and 10mg/320mg/25mg (amlodipine/ Indication For the treatment of hypertension valsartan/ Approval Date April 30, 2009 hydrochlorothiazide) Anticipated Launch Date‡ May 2009 Novartis Pharmaceuticals Corporation Creon® Dosage Form; Strengths Capsule, oral, delayed-release; 6,000 USP units of lipase, 19,000 USP units of protease, 30,000 USP units of amylase; (pancrelipase) 12,000 USP units of lipase, 38,000 USP units of protease, 60,000 USP units of amylase; 24,000 USP units of lipase, 76,000 USP units of protease, 120,000 USP units of amylase Indication For the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Solvay Approval Date April 30, 2009 Pharmaceuticals Anticipated Launch Date‡ Third quarter 2009 Cycloset® Dosage Form; Strength Tablet, oral; 0.8 mg (bromocriptine Indication Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus mesylate) Approval Date May 5, 2009 VeroScience/S2 Anticipated Launch Date‡ 2010 Therapeutics Fanapt™ Dosage Form; Strengths Tablet, oral; 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg (iloperidone) Indication For the acute treatment of schizophrenia in adults Vanda Approval Date May 6, 2009 Pharmaceuticals Anticipated Launch Date‡ Third quarter 2009 Cetraxal® Otic Dosage Form; Strength Solution, otic; 0.2% (ciprofloxacin) Indication For the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus Laboratorios Approval Date May 1, 2009 SALVAT Anticipated Launch Date‡ Second quarter 2009 ACTOplus met® XR Dosage Form; Strengths Tablet, oral, extended-release; 15 mg/1000 mg and 30mg/1000 mg (pioglitazone/ Indication Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are metformin already treated with pioglitazone and metformin or who have inadequate glycemic control on pioglitazone alone or extended release) metformin alone Approval Date May 12, 2009 Takeda Anticipated Launch Date‡ Fourth quarter 2009 Pharmaceuticals Lamictal® ODT™ Dosage Form; Strengths Tablet, orally disintegrating; 25 mg, 50 mg, 100 mg and 200 mg (lamotrigine) Indications Indicated for the long-term treatment of bipolar I disorder in people 18 years or older who have been treated with other medicine; as adjunctive therapy to treat certain types of seizures (partial seizures, primary generalized tonic-clonic seizures, generalized seizures of Lennox-Gastaut syndrome) in people two years or older or alone when changing from other medicines used to treat partial seizures in people 16 years or older. Approval Date May 8, 2009 GlaxoSmithKline Anticipated Launch Date‡ July 2009 Samsca™ Dosage Form; Strengths Tablet, oral; 15 mg, 30 mg and 60 mg (tolvaptan) Indication Indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium < 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure, cirrhosis, and Syndrome of Inappropriate Antidiuretic Hormone. Otsuka America Approval Date May 19, 2009 Pharmaceutical Anticipated Launch Date‡ Second quarter 2009 Adcirca™ (tadalafil) Dosage Form; Strength Tablet, oral; 20 mg Indication Indicated for the treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability. United Approval Date May 22, 2009 Therapeutics Anticipated Launch Date‡ August 2009 Recent Supplemental New Drug Application (sNDA) Approvals1,2* Revatio™ Dosage Form Tablet, oral (sildenafil citrate) Indication To delay clinical worsening in patients with pulmonary arterial hypertension (WHO Group I) Approval Date May 7, 2009 Comments This is a new indication for an already approved product. Pfizer This product will be available through the CVS Caremark Specialty Pharmacy Services Network. Azor® (amlodipine Dosage Form Tablet, oral besylate/ Indication For the treatment of hypertension as initial therapy in patients likely to need multiple antihypertensive agents to achieve olmesartan their blood pressure goals medoxomil) Approval Date May 11, 2009 Daiichi Sankyo Co., Comments This is a new indication for an already approved product. Ltd. Risperdal® Consta® Dosage Form Injection, intramuscular (risperidone) Indication For use as adjunctive therapy with lithium or valproate for the maintenance treatment of bipolar I disorder; and as monotherapy for the maintenance treatment of bipolar I disorder Ortho-McNeil Approval Date May 15, 2009 Janssen Comments This is a new indication for an already approved product. Prograf® Dosage Forms Capsule, oral; and Injection, intravenous (tacrolimus) Indication For the prophylaxis of organ rejection in kidney transplant patients in combination with mycophenolate mofetil Approval Date May 19, 2009 Astellas Pharma Comments This is a new indication for an already approved product.
Recent Supplemental Biologic License Application (sBLA) Approvals1,2* Avastin® Dosage Form Injection, intravenous (bevacizumab) Indication For the treatment of glioblastoma, as a single agent for patients with progressive disease following prior therapy Roche Approval Date May 5, 2009 Laboratories/ Comments This is a new indication for an already approved product. Genentech, Inc. This product will be available through the CVS Caremark Specialty Pharmacy Services Network. Cimzia® Dosage Form Injection, subcutaneous (certolizumab Indication For the treatment of adults with moderately to severely active rheumatoid arthritis pegol) Approval Date May 13, 2009 UCB Comments This is a new indication for an already approved product. Pharmaceuticals This product will be available through the CVS Caremark Specialty Pharmacy Services Network. Inc.
* Adapted from RxPipeline Services Week In Review. For more information contact: [email protected]
www.caremark.com News Medication Safety Information regarding selected medication safety issues can be found on the CVS Caremark Web site at www.caremark.com > Health Professional Services > Drug Safety Alerts.
Additional Labeling for Over-the-Counter (OTC) Pain Relievers and Fever Reducers4 On April 28, 2009, the FDA issued a final rule that requires manufacturers of OTC pain relievers and fever reducers to include additional labeling regarding the potential risk of internal bleeding and liver damage. Exceeding the recommended dosage of products that contain acetaminophen has been associated with liver damage, while stomach bleeding can occur with frequent use of non-steroidal anti-inflammatory drugs such as aspirin, ibuprofen, naproxen and ketoprofen. Because these OTC medications are easily accessible and are commonly used in children and adults, the FDA deems that the potential for harm associated with their use needs to be clearly specified. The new labeling will help educate consumers on proper use and medication safety to reduce their exposure to risk.
Suicidal Behavior or Ideation and Antiepileptic Drugs5,6 In December 2008, the FDA issued a safety alert regarding an increased risk of suicidal thoughts or behavior with the use of antiepileptic drugs. The alert was based on the pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy, as well as psychiatric disorders and other conditions. The risk of suicidal behavior has been attributed to all antiepileptic drugs used for any indication (i.e., epilepsy, psychiatric disorders, migraine and neuropathic pain syndromes). On May 5, 2009, the FDA notified health care professionals that it has approved product labeling for this risk and will require the issuance of medication guides to patients each time an antiepileptic drug is dispensed.
New Warnings on Topical Testosterone Gel products (AndroGel 1% and Testim 1%)7 On May 7, 2009, the FDA announced it would require boxed warnings and detailed patient use instructions on two prescription topical testosterone products, AndroGel 1% and Testim 1%. The action is intended to highlight the adverse effects that could occur in children as a result of secondary exposure, should gel users fail to follow instructions. Both medications are approved for use in men who either no longer produce testosterone or produce it in very low amounts. The FDA has received reports of adverse events in eight children with secondary exposure to testosterone, resulting in inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido, or aggressive behavior. The FDA is also requiring manufacturers to develop a Medication Guide as part of a Risk Evaluation and Mitigation Strategy to ensure that the benefits of these products continue to outweigh their potential risks.
References 1. CVS Caremark. RxPipeline. Available at: www.caremark.com/wps/portal/client. Accessed May 1, 2009; May 8, 2009; May 15, 2009; May 22, 2009; and May 29, 2009. 2. Drugs@FDA. Rockville, MD: Food and Drug Administration, Center for Drug Evaluation and Research. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed April 2009. 3. Facts & Comparisons. Facts & Comparisons Web site. http://www.factsandcomparisons.com/. Accessed April 2009. 4. FDA News. FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely. Food and Drug Administration Web site. http://www.fda.gov/bbs/topics/NEWS/2009/NEW02004.html. Accessed May 26, 2009. 5. FDA MedWatch. Antiepileptic Drugs. Food and Drug Administration Web site. http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic. Accessed May 26, 2009. 6. FDA Drug Information. Suicidal Behavior and Ideation and Antiepileptic Drugs. Food and Drug Administration Web site. http://www.fda.gov/cder/drug/infopage/antiepileptics/default.htm. Accessed May 26, 2009. 7. FDA News. Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide. Food and Drug Administration Web site. http://www.fda.gov/bbs/topics/NEWS/2009/NEW02011.html. Accessed May 26, 2009.
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