Glenmark Generics receives USFDA nod for Norgestimate and Ethinyl Estradiol tablets

09 Apr 2012 Evaluate

Glenmark Generics Inc USA, a subsidiary of Glenmark Generics, has been granted final approval for their abbreviated new drug application (ANDA) by the United States Food and Drug Administration (USFDA) for Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg. This approval marks Glenmark's tenth female hormonal product authorized for distribution by the USFDA.

Glenmark's approved product is their generic version of Ortho Cyclen tablets by Janssen Pharmaceuticals, Inc. indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

According to IMS Health for the 12 month period ending December 2011, Norgestimate and Ethinyl Estradiol Tablets USP 0.25 mg/0.035 mg garnered total market sales of approximately $88 million.

Glenmark has a number of ANDA’s currently pending approval with the USFDA in this therapeutic segment as well as a sizeable concentration of their pipeline in various stages of development. The company's current portfolio consists of 79 generic products authorized for distribution in the US market and 39 ANDA's filed with the USFDA pending approval.

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