Glenmark Pharmaceuticals has received final approval from the US Food & Drug Administration (FDA) for its nystatin and triamcinolone acetonide cream (100,000 units per gm and 1 mg per gm) - a generic version of Mycolog-II cream of Delcor Asset Corporation.
Mycolog-II, which is no loger being marketed in the US, is indicated for the treatment of cutaneous candidiasis (a fungal infection of skin).
According to IMS Health sales data for the 12 months period ending August 2016, the Mycolog-II cream market (which includes brand and all available therapeutic equivalents) achieved annual sales of approximately $ 120.9 million.
Glenmark's current porfolio consists of 111 products authorised for distribution in the US marketplace and 60 ANDAs pending approval with the US FDA.
