Glenmark Pharmaceuticals (Glenmark), a manufacturer of generic formulation products and API, said Glenmark Generics Inc., USA has secured final approval from United States Food & Drug Administration (US FDA) for the oral contraceptive, Levonorgestrel/ Ethinyl Estradiol Tablets USP, 0.09 mg/ 0.02 mg.
Levonorgestrel/ Ethinyl Estradiol Tablets USP is the therapeutic equivalent of Lybrel of Wyeth Pharmaceuticals, Inc.
According to IMS Health sales data for the 12 month period ended February 2015, the Lybrel market achieved annual sales of nearly USD 6.4 million.
Glenmark plans to commence shipping of Levonorgestrel/ Ethinyl Estradiol Tablets, 0.09 mg/ 0.02 mg immediately.
Shares of the company gained Rs 11.7, or 1.35%, to trade at Rs 876.40. The total volume of shares traded was 42,412 at the BSE (10.18 a.m., Friday).