Monday, May 4, 2009

New generics

Zydus announced that it has received final FDA approval for its Abbreviated New Drug Application (ANDA) for Topiramate Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg. Topiramate tablets are the generic version of Ortho-McNeil-Janssen's Topamax Tablets.

Ranbaxy announced the FDA has approved its ANDA to market and manufacture Ramipril Capsules 5 mg and 10 mg. The FDA had determined the Ranbaxy formulations to be bioequivalent and as having the same therapeutic effect as that of the reference-listed drug, Altace, by King.

Teva announced the FDA granted final approval of its ANDA to market Minocycline HCl Capsules, its generic version of Medicis' acne treatment Solodyn Extended-Release Tablets, 45 mg, 90 mg, and 135 mg.
Ranbaxy announced that it has received an approval from the FDA for its ANDA for Quinapril + HCTZ Tablets (quinapril hydrochloride and hydrochlorothiazide), 10 mg/12.5 mg, 20 mg/12.5 mg, and 20mg/25mg. The FDA determined the Ranbaxy formulations to be bioequivalent and as having the same therapeutic effect as that of the reference-listed drug, Pfizer's Accuretic Tablets.

Full Coverage: http://www.modernmedicine.com/modernmedicine/Over+the+Counter/New-products-Rx-generic-OTC-May-2009/ArticleStandard/Article/detail/596058?contextCategoryId=40159

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