Saturday 31 May, 2008

Drug approval/Launch: Topiramate (Lupin), Bupropion Hydrochloride (Teva), Cetirizine Hydrochloride Syrup (Teva)

Lupin got tentative Approval for Topiramate Tablets
Lupin announced that it has received tentative approval for the Company's ANDA for Topiramate tablets, 25 mg, 50 mg, 100 mg and 200 mg from the U.S. Food and Drug Administration (USFDA). Lupin's Topiramate tablets are the AB-rated generic equivalent of Ortho-McNeil's TOPAMAX(R) tablets, indicated for the treatment of seizures.
Teva Announces Launch of Generic Wellbutrin XL Tablets, 150 mg
Teva Pharma announced that it has begun commercially shipping Bupropion Hydrochloride Extended-Release Tablets, 150 mg, the generic version of Biovail Corporation's antidepressant Wellbutrin XL(R) Tablets, pursuant to its March 2007 agreement with Anchen Pharmaceuticals, Inc. Wellbutrin XL(R) Tablets, 150 mg, marketed by GlaxoSmithKline, had U.S. sales of approximately $930 million for the 12 months ended March 2008, according to IMS data.
Teva Launch Cetirizine Hydrochloride Syrup
Teva Pharmaceuticals announced the introduction and availability of Cetirizine Hydrochloride Syrup. This product is AA rated and bioequivalent to Zyrtec®* Syrup. Cetirizine Hydrochloride Syrup is available in a 5 mg/5 mL strength, in bottle sizes of 120 mL and 473 mL.

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