Glenmark Pharmaceuticals Inc., USA (blenmare) has been granted tinal approval by the United States Food & Drug Administration (U.S. FDA) for Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.03 mg, the generic version of Yasmin Tablets of Bayer HealthCare Pharmaceuticals Inc. (Bayer) and for Levonorgestrel Tablet, 1.5 mg, the generic version of Plan B One-Step Tablet of Teva Branded Pharmaceutical Products R&D, Inc., for over-the-counter (OTC) use as recommended in the submitted labeling.
According to IMS Health sales data for the 12 month period ending January 2016, the Yasmin market achieved annual sales of approximately USD 131.7 million. According to IMS Health sales data for the 12 month period ending January 2016, the Plan B One-Step Tablet OTC market' achieved annual sales of approximately USD 45.2 millions.
Glenmark's current portfolio consists of 112 products authorized for distribution in the U.S. marketplace and 57 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glennntinues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
Shares of the company declined Rs 2.95, or 0.36%, to trade at Rs 819.15. The total volume of shares traded was 25,507 at the BSE (3.17 p.m., Monday).