Glenmark Pharmaceuticals (Glenmark), a manufacturer of generic formulation products and API, has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for the extended-cycle oral contraceptive, Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg, the AB-rated generic version of Seasonale by Teva Women's Health.
Today approval marks Glenmark's 12th oral contraceptive and 2nd extended-cycle oral contraceptive authorized for distribution by the U.S. FDA. Glenmark plans to commence shipping of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg immediately.
Shares of the company gained Rs 9.20, or 1.05%, to trade at Rs 889.20 at the BSE (Monday).