Drug Topics- August 11, 2008

62 DRUG TOPICS AUGUST 11, 2008 www.drugtopics.com >>> New Products Rx New Drug Sirion Therapeutics Inc. (www.siriontherapeutics. com) received FDA approval for Durezol (difluprednate ophthalmic emulsion) 0.05%, a topical steroid for the treatment of postoperative ocular inflammation and pain. The approval came after a six-month priority review. Sirion plans to make Durezol commercially available later this year. New Dosage Eisai Corp. of North America (www.eisai.com), a wholly owned subsidiary of Tokyo-based Eisai Co. Ltd., received FDA approval for ACIPHEX (rabeprazole sodium) 20 mg for the short-term treatment (up to eight weeks) of gastroesophageal reflux disease (GERD), including heartburn, in adolescents ages 12 and older. The safety and effectiveness of ACIPHEX has not been established for children under the age of 12. New Indication GlaxoSmithKline (www.gsk.com) announced FDA approval for AVODART (dutasteride) in combination with tamsulosin for the treatment of symptomatic enlarged prostate. The approval was based on two-year results of the CombAT (Combination of Avodart and Tamsulosin) study, one of the largest clinical trials to date of men with enlarged prostate. Boehringer Ingelheim Pharmaceuticals Inc. (http:// us.boehringer-ingelheim.com) received FDA approval for its Aptivus (tipranavir) capsules/oral solution with dosing information for treatment-experienced pediatric patients between the ages of two and 18 who are infected with HIV-1. The oral solution formulation, which is a new dosage form of APTIVUS, was also approved for treatment-experienced adults. The oral solution formulation will be available in the United States beginning in mid-September. New Generics Teva Pharmaceuticals (www. tevausa.com) is making available its Ramipril Capsules. The product is AB rated and bioequivalent to Altace Capsules. Ramipril Capsules are available in 2.5-mg, 5-mg, and 10-mg strengths, in bottle sizes of 100. The FDA approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions. The labeling of the generic risperidone may differ from that of Risperdal because some uses of the drug are protected by patents and exclusivity. Janssen (www.janssen.com), a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., has launched an authorized generic version of Risperdal through Patriot Pharmaceuticals LLC. Parenta Pharmaceuticals (www.parentarx.com), the U.S. subsidiary of Austria-based Ebewe Pharma, launched Granisetron Hydrochloride Injection, the generic equivalent of Hoffmann-La Roche’s Kytril. The company will supply Granisetron Hydrochloride in AP-rated, bar-coded, latex-free vials in the following presentations: 0.1 mg/mL and 1 mg/mL singledose vials and 4 mg/4mL (1 mg/mL) multidose vials. Granisetron Hydrochloride Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. Watson Pharmaceuticals Inc. (www.watson.com) announced that, under a supply agreement with Solvay ADVERTISERS INDEX ACIPHEX (Pricara) INSERT AMITIZA (Takeda Pharmaceuticals) 17-19,61 CANCER CARE (Ortho-Biotech) 41 CEFEPIME INJECTION (Baxter HealthCare) HSE 7 CORPORATE (Eisai) 23 CORPORATE (EPS, Inc.) HSE 3 CORPORATE (Mylan Pharmaceuticals) 11 CORPORATE (Parata Systems) 13 CORPORATE (QS/1) 15 CORPORATE (Reese Pharmaceutical) 65 CORPORATE (ScriptPro) 7 CORPORATE (Stericycle) 39 CORPORATE (Thomson PDR) 31 CORPORATE (United Drugs) 21 DORIPENE (Ortho McNeil) HSE 5 EFFIENT B2B (Daiichi-Sankyo Inc.) 9 FACTS & COMPARISONS (Wolters Kluwer Health) 36-37 FASTFILL 120 (AmerisourceBergen) 5 GLUCAGEN HYPOKIT (Novo Nordisk) IBC,BC LEXAPRO (Forest Laboratories) INSERT,29 LICEMD (Combe Inc) 43 OPTIVE (Allergan Inc) 32 PLAN B (Duramed Pharmaceuticals) 63-64 PRONTO (Church & Dwight) 27 RESTASIS (Allergan Inc) 33,34 TOPAMAX (Ortho McNeil) 44-47 YAZ (Bayer HealthCare Pharmaceuticals) IFC,1-3 IFC-Inside front cover IBC-Inside back cover BC-Back cover http://www.drugtopics.com http://www.gsk.com http://www.siriontherapeutics http://us.boehringer-ingelheim.com http://us.boehringer-ingelheim.com http://www.eisai.com http://www.tevausa.com http://www.tevausa.com http://www.janssen.com http://www.parentarx.com Cover2 http://www.watson.com

Table of Contents Feed for the Digital Edition of Drug Topics- August 11, 2008

Drug Topics- August 11, 2008 Contents Latebreakers Letters DEA Proposes Rule To Allow Electronic Prescriptions for Controlled Substances Merger, Medicare Reform Could Mean Broader E-Prescribing Adoption New Combination Pill Approved for Type 2 Diabetes New Eczema Guildlines Promote Use of Emollients, Then Topical Corticosteroids Agencies Flush Original Strategies in Favor of Promoting Drug Take-Back Programs JP at Large: You Laughing at Me? Pharmacists Find Themselves at Mercy of Prior Authorization State Law Requiring PBM Transparency See Some Gains, Some Losses Global Counterfeiting Still Growing, Says U.S. Commerce Official FDA Saftey Page: Prophylthiouracil Still Confused with Purinethol (mercaptopurine) New Products Bring Lice Treatment to a Head NACDS Marketplace Showcases New Product that Fill Unmet Needs Update on Respiratory Tract Infections Execs Share War Stories About Adopting Technology in their Stores New Products Advertisters Index Classified Viewpoint: Medicare Part D Revisions sorely needed

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