Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Fingolimod Capsules, 0.5 Mg, the generic version of Gilenya® Capsules of Novartis Pharmaceuticals Corp.
According to IMS Health sales data for the 12 month period ending January 2017, Gilenya® Capsules, 0.5 mg achieved annual sales of approximately $2.03 billion*.
Glenmark's current portfolio consists of 112 products authorized for distribution in the U.S. marketplace and approximately 65 ANDA's pending approval with the U.S. FDA. 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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*IMS Health National Sales Perspectives: Retail & Non-Retail, January 2017
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