Glenmark Pharmaceuticals’ subsidiary - Glenmark Generics Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for the oral contraceptive, Levonorgestrel/Ethinyl Estradiol Tablets USP, 0.09 mg/0.02 mg, the therapeutic equivalent of Lybrel of Wyeth Pharmaceuticals, Inc. (which is no longer being marketed in the United States).
Lybrel 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 February 2015, the Lybrel market achieved annual sales of approximately $6.4 million.
This approval marks Glenmark’s 11th oral contraceptive authorized for distribution by the US FDA. Glenmark plans to commence shipping of Levonorgestrel/Ethinyl Estradiol Tablets, 0.09 mg/0.02 mg immediately.
Glenmark’s current portfolio consists of 97 products authorized for distribution in the US marketplace and 68 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.
