Glenmark Generics receives USFDA nod for desogestrel & ethinyl estradiol tablets

03 Apr 2012 Evaluate

Glenmark Generics Incorporation, USA, a subsidiary of Glenmark Generics, has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (USFDA) for Desogestrel and Ethinyl Estradiol Tablets USP, 0.15mg/0.02 mg and Ethinyl Estradiol Tablets USP 0.01mg. The company will market its product as Viorele tablets and plan to commence shipping immediately.

Viorele tablets are Glenmark’s generic version of Mircette tablets by Teva Women’s Health Inc. Viorele is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Glenmark’s current portfolio consists of 78 products authorized for distribution in the US marketplace and 40 ANDA's pending approval with the USFDA.

Glenmark Generics Incorporation (GGI), USA is the North American division of Glenmark Generics dedicated to the manufacture, marketing and distribution of generic pharmaceutical products. GGI (formerly Glenmark Pharmaceuticals Incorporation, USA) established operations in 2003 and was a subsidiary of Glenmark Pharmaceuticals.

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