Glenmark Pharma’s arm gets US FDA approval for AshlynaTM Tablets

25 Feb 2015 Evaluate

Glenmark Generics Inc (GGI), a step down subsidiary of Glenmark Pharmaceuticals has received US Food and Drug Administration (US FDA) approval and introduced AshlynaTM (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Extended-Cycle Oral Contraceptive Tablets, the generic equivalent of Seasonique by Teva Women’s Health, in US.

Seasonique is indicated for use by women to prevent pregnancy. According to IMS Health sales data for the 12 month period ending December 2014, the Seasonique market achieved annual sales of approximately $159.1 million.

The approval marks Glenmark’s 10th oral contraceptive and first extended-cycle oral contraceptive authorized for distribution by the U.S. FDA. Glenmark is planning to commence shipping of Ash lynaTM immediately.

Glenmark’s current portfolio consists of 94 products authorized for distribution in the U.S. marketplace and 75 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

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