Glenmark receives US FDA approval for oral contraceptive Ashlyna

US Food and Drug Administration (US FDA) has granted Glenmark Generics Limited, a subsidiary of Glenmark Pharmaceuticals Limited focusing on generic and active pharmaceutical ingredients (APIs), marketing approval for its Ashlyna (levonorgestrel/ethinyl estradiol and ethinyl estradiol) extended-cycle oral contraceptive tablets, the generic equivalent of Seasonique by Teva Women’s Health.
 
According to IMS Health sales data for the 12 month period ending December 2014, Seasonique, which is indicated for use by women to prevent pregnancy, has recorded annual sales of $ 159.1 million. Today’s approval marks Glenmark’s tenth oral contraceptive and first extended-cycle oral contraceptive authorised for distribution by the US FDA. Glenmark said that it plans to commence shipping of Ashlyna immediately.
 
Glenmark’s current portfolio consists of 94 products authorised for distribution in the US marketplace and 75 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark Generics continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.