Glenmark receives USFDA approval for Drospirenone, Ethinyl Estradiol Tablets

19 Aug 2015 Evaluate

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg, the generic version of Yaz Tablets of Bayer Healthcare Pharmaceuticals Inc. (Bayer). The pharma major plans to commence shipping of Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg immediately.

According to IMS Health sales data for the 12 month period ending June 2015, the Yaz market achieved annual sales of approximately $170.1 million.

Glenmark’s current portfolio consists of 101 products authorized for distribution in the US marketplace and 64 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.



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