TrendsRx® September 2009 TrendsRx®Drug Pipeline & News Volume 5, Number 9 Pipeline Highlights: July 29, 2009 – August 27, 2009 and Recent Selected Health Care News Highlights
Selected Generic Product Approvals/Launches1,2*
azelastine Dosage Form; Strength Solution, ophthalmic; 0.05% (Optivar®) Approval Date† August 3, 2009 Anticipated Launch Date‡ December 1, 2009 Comments The reference brand is used for the treatment of itching of the eye associated with allergic conjunctivitis. This product is AT-rated and will be available from a single generics manufacturer. oxaliplatin Dosage Form; Strengths Injection, intravenous infusion; 50 mg/vial and 100 mg/vial (Eloxatin®) Approval Date† August 11, 2009 Launch Date‡ August 11, 2009 Comments The reference brand, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for: - adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor - treatment of advanced colorectal cancer This product is AP-rated and will be available from multiple generics manufacturers. The manufacturer of the reference brand is involved in litigation with manufacturers of the generic drug and the FDA concerning the FDA’s approval of generic brands. tacrolimus Dosage Form; Strengths Capsule, oral; 0.5 mg, 1 mg and 5 mg (Prograf®) Approval Date† August 10, 2009 Launch Date‡ August 11, 2009 Comments The reference brand is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants. This product is AB-rated and will be available from a single generics manufacturer. The manufacturer of this product and the manufacturer of the reference drug are involved in ongoing litigation.
clonidine TDS Dosage Form; Strengths Extended-release film, transdermal; 0.1 mg/24 hours, 0.2 mg/24 hours and 0.3 mg/24 hours (Catapress-TTS®) Approval Date† August 18, 2009 Launch Date‡ August 20, 2009 Comments The reference brand is indicated for the treatment of hypertension. This product is AB-rated and will be available from a single generics manufacturer.
clindamycin Dosage Form; Strength Gel; topical; 1% clindamycin/5% benzoyl peroxide phosphate/benzoyl Approval Date† August 11, 2009 peroxide (BenzaClin®) Launch Date‡ August 27, 2009 Comments The reference brand is used for the topical treatment of acne vulgaris. This product is AB-rated and will be available from a single generics manufacturer.
Continued on next page www.caremark.com Recent New Drug Application (NDA) Approvals1,2*
Tyvaso™ Dosage Form; Strength Solution, inhalation; 2.9 mL ampule containing 1.74 mg treprostinil (0.6 mg/mL) (treprostinil) Indication For the treatment of pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III symptoms, to increase walk distance United Therapeutics Approval Date July 30, 2009 Corporation/ Anticipated Launch Date‡ Early September 2009 Lung Rx, Inc. Comments This is a new formulation of an already approved drug.
Invega® Sustenna™ Dosage Form; Strengths Extended-release suspension for intramuscular injection; 39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/1 mL (paliperidone and 234 mg/1.5 mL palmitate) Indications For the acute and maintenance treatment of schizophrenia in adults Ortho-McNeil-Janssen Approval Date July 31, 2009 Pharmaceuticals, Anticipated Launch Date‡ Third quarter 2009 Inc. Comments This is a new formulation of an already approved drug.
Lipsovir® Dosage Form; Strength(s) Cream, topical; Strength(s) not available at time of publication (acyclovir/ Indications For the early treatment of recurrent herpes labialis (cold sores), to reduce the likelihood of ulcerative cold sores, and to hydrocortisone) shorten lesion healing time in adults and children 12 years of age and older Approval Date August 3, 2009 Medivir Anticipated Launch Date‡ Third quarter 2009
Livalo® Dosage Form; Strengths Tablet, oral; 1 mg, 2 mg and 4 mg (pitavastatin) Indications For the primary treatment of hypercholesterolemia and combined dyslipidemia Kowa Pharmaceuticals Approval Date August 3, 2009 America Inc. Anticipated Launch Date‡ First quarter 2010
Embeda™ Dosage Form; Strengths Extended-release capsule, oral; 20 mg/0.8mg, 30 mg/1.2 mg, 50 mg/2 mg, 60 mg/2.4 mg, 80 mg/3.2 mg and 100 mg/4 mg (morphine/ Indication For the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an naltrexone) extended period of time. Embeda is not intended for use as a PRN analgesic. King Approval Date August 13, 2009 Pharmaceuticals, Inc. Anticipated Launch Date‡ September, 2009
Saphris® (asenapine) Dosage Form; Strengths Tablet, sublingual; 5 mg and 10 mg Indications For the acute treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults Schering-Plough Approval Date August 13, 2009 Corporation Anticipated Launch Date‡ Fourth quarter 2009
Sabril® (vigabatrin) Dosage Forms; Strengths Powder for solution, oral; 500 mg Tablet, oral; 500 mg Indication - For use as monotherapy in pediatric patients one month to two years of age with infantile spasms (IS) for whom the potential benefits outweigh the potential risk of vision loss - For use as an adjunctive therapy for adult patients with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss Approval Date August 21, 2009 Lundbeck Inc. Anticipated Launch Date‡ Third quarter 2009
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www.caremark.com Recent Product Launches1,2*
Effient™ (prasugrel) Dosage Form; Strengths Tablet, oral; 5 mg and 10 mg Indications For the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: Daiichi Sankyo Co., - Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) Ltd/ Eli Lilly and - Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI Company Launch Date‡ August 5, 2009 Ilaris® (canakinumab) Dosage Form; Strength Injection, subcutaneous; 180 mg/6 mL vial Indication For the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in adults and children 4 years of age and older, including Novartis - Familial Cold Autoinflammatory Syndrome (FCAS) Pharmaceuticals - Muckle-Wells Syndrome (MWS) Corporation Launch Date‡ August 7, 2009 Onglyza™ (saxagliptin) Dosage Form; Strengths Tablet, oral; 2.5 mg and 5 mg Bristol-Myers Indication For use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Squibb/AstraZeneca Launch Date‡ August 7, 2009 Edluar™ (zolpidem) Dosage Form; Strengths Tablet, sublingual; 5 mg and 10 mg Meda Indication For the short-term treatment of insomnia characterized by difficulties with sleep initiation Pharmaceuticals/ Launch Date‡ August 11, 2009 Orexo Plan B® One-Step Dosage Form; Strength Tablet, oral; 1.5 mg (levonorgestrel) Indication For prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure Duramed Launch Date‡ August 11, 2009 Pharmaceuticals Acuvail™ Dosage Form; Strength Solution, ocular; 0.45% (ketorolac Indication For the treatment of pain and inflammation following cataract surgery tromethamine) Launch Date‡ August 11, 2009 Allergan, Inc 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 SALVAT USA Inc. Launch Date‡ August 11, 2009 Colcrys™ (colchicine) Dosage Form; Strength Tablet, oral; 0.6 mg Mutual Indications For the treatment of familial Mediterranean fever (FMF) in adults and children 4 years of age and older and the treatment of Pharmaceutical acute gout flares when taken at the first sign of a flare Company, Inc. Launch Date‡ August 14, 2009
Recent Biologic License Application (BLA) Approvals1,2*
Extavia® Dosage Form; Strength Injection, subcutaneous; 0.3 mg (interferon beta-1b) Indication For the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations Novartis Approval Date August 14, 2009 Pharmaceuticals Launch Date‡ Third quarter 2009 Corporation
Hiberix® Dosage Form; Strength Solution for injection, intramuscular; 0.5 mL dose (Haemophilus b Indication For active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b Conjugate Vaccine in children 15 months through 4 years of age (prior to fifth birthday) [Tetanus Toxoid Approval Date August 19, 2009 Conjugate]) Launch Date‡ Early September 2009 GlaxoSmithKline
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www.caremark.com Recent Supplemental New Drug Application (sNDA) Approvals1,2*
Invega® Dosage Form Extended-release tablet, oral (paliperidone) Indications For the acute treatment of schizoaffective disorder as monotherapy and the acute treatment of schizoaffective disorder as an adjunct to mood stabilizers and/or antidepressants ALZA Corporation Approval Date July 31, 2009 and Janssen Cilag Comments This is a new indication for an already approved product. Manufacturing, LLC This product was previously indicated for the acute and maintenance treatment of schizophrenia only. Avastin® Dosage Form Single use vial, intravenous infusion (bevacizumab) Indication For the treatment of metastatic renal cell carcinoma in combination with interferon-alpha Approval Date July 31, 2009 Comments This is a new indication for an already approved product. Genentech, Inc Refer to full Prescribing Information for a complete list of indications. Tracleer® Dosage Form Tablet, oral (bosentan) Indication For the treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO Functional Class II to IV symptoms to improve exercise capacity and decrease clinical worsening Approval Date August 7, 2009 Comments This is a new indication for an already approved product. Actelion This product was previously indicated for the treatment of pulmonary hypertension in patients with WHO functional class III Pharmaceuticals Ltd and IV symptoms.
* Adapted from RxPipeline Services Week In Review. For more information, contact: [email protected]
FDA issues Early Communication about ongoing safety review of orlistat4,5 On August 24, 2009, the FDA announced that it is reviewing adverse event reports of liver injury associated with the weight- loss drug orlistat. Orlistat is marketed as the prescription product Xenical® (orlistat 120 mg) and the over-the-counter product Alli® (orlistat 60 mg). Between 1999 and October 2008, the FDA received 32 reports of serious liver injury, including 27 reports of hospitalization and 6 reports of liver failure, in patients using the medication. Thirty of those cases occurred outside the United States. The most commonly reported adverse events were jaundice, weakness and abdominal pain.
Data analysis is ongoing, and a definitive correlation between the use of orlistat and liver injury has not been established at this time. Consumers currently taking either orlistat product should continue as directed. If consumers experience symptoms of liver injury such as fatigue, fever, jaundice or brown urine while taking orlistat, they are encouraged to contact their health care providers.
References 1. CVS Caremark. RxPipeline. Available at: www.caremark.com/wps/portal/client. Accessed August 7, 2009; August 14, 2009; August 21, 2009; and August 28, 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 August 2009. 3. Facts & Comparisons. Facts & Comparisons Web site. http://www.factsandcomparisons.com/. Accessed August 2009. 4. FDA Drug Safety and Availability. FDA issues Early Communication about ongoing safety review of weight loss drug orlistat. Review includes both prescription drug Xenical and OTC drug Alli. Food and Drug Administration Web site. http://www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ucm180057.htm. Accessed August 26, 2009. 5. FDA Drug Safety and Availability. Early communication about an ongoing safety review (of) orlistat (marketed as Alli and Xenical). Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsand Providers/DrugSafetyInformationforHeathcareProfessionals/ucm179166.htm. Accessed August 26, 2009.
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