Glenmark Receives Approval for Nystatin Cream

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Glenmark Pharma has said that Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration {U.S. FDA) for Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/g, the generic version of Mycolog-11 (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-11 {nystatin and triamcinolone acetonide) Cream, 100,000 units/g, 0.1% market' achieved annual sales of approximately USD 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.