Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for the extended-cycle oral contraceptive, Levonorgestrel/Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg, the AB-rated generic version of Seasonale by Teva Women’s Health.
Seasonale is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. According to IMS Health sales data for the 12 month period ending April 2015, the Seasonale market achieved annual sales of approximately $53.7 million.
This approval marks Glenmark’s 12th oral contraceptive and 2nd extended-cycle oral contraceptive authorized for distribution by the USFDA. Glenmark plans to commence shipping of Levonorgestrel/Ethinyl Estradiol Tablets, 0.15 mg/0.03 mg immediately.
Glenmark’s current portfolio consists of 99 products authorized for distribution in the US marketplace and 66 ANDA’s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
