Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (US FDA) for raloxifene hydrochloride tablets USP, 60 mg, the therapeutic equivalent to the reference listed drug product, Evista tablets, 60 mg, of Eli Lilly and Company.
According to IMS Health sales data for the 12 month period ending January 2016, the Evista achieved annual sales of approximately $336.5 million.
Glenmark’s current portfolio consists of 109 products authorised for distribution in the US marketplace and 60 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and the growth of its existing pipeline and portfolio.