Glenmark Pharmaceuticals gets ANDA approval for Raloxifene Hydrochloride Tablets USP, 60 mg

23 Mar 2016 Evaluate

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) 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 Market achieved annual sales of approximately $336.5 million.

Glenmark's current portfolio consists of 109 products authorized for distribution in the U.S. marketplace and 60 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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