Glenmark Pharmaceuticals USA has been granted final approval by the US Food & Drug Administration (USFDA) for the "nystatin and triamcinolone acetonide cream USP, 100,000 units/gram and 1 mg/g," the company said in a BSE filing.
The product is the generic version of Mycolog-II cream of Declor Asset Corporation, it added.
According to IMS Health sales data for the 12 month period ending August 2016, Mycolog-II cream achieved annual sales of around USD 120.9 million, Glenmark said.
The company's current portfolio consists of 111 products authorised for distribution in the US marketplace and 60 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA.
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