Glenmark Generics Inc., USA, the subsidiary of Glenmark Generics Ltd, has received US FDA approval for Ashlyna (levonorgestrel/ethinyl estradiol and ethinyl estradiol) extended-cycle oral contraceptive tablets, the generic equivalent of Seasonique by Teva Women’s Health.

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 USD 159.1 million.

The approval marks Glenmark’s 10th oral contraceptive and first extended-cycle oral contraceptive authorized for distribution by the US FDA. Glenmark plans to commence shipping of Ashlyna immediately.

Glenmark’s current portfolio consists of 94 products authorized for distribution in the US market place and 75 ANDA’s pending approval with the US 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.