Glenmark bags FDA approval for new generic

Glenmark Pharmaceuticals receives ANDA approval for Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/g

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Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (US FDA) for Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/g, the generic version of Mycolog-II (nystatin and triamcinolone acetonide) Cream, 100,000 units/g, 0.1%, of Delcor Asset Corporation (which is no longer being marketed in the United States).

According to IMS Health sales data for the 12 month period ending August 2016, the Mycolog-II (nystatin and triamcinolone acetonide) Cream, 100,000 units/g, 0.1% market1 achieved annual sales of approximately $120.9 million.

Glenmark's current portfolio consists of 111 products authorized for distribution in the U.S. marketplace and 60 ANDA's pending approval with the U.S. FDA.

 

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