Glenmark Pharmaceuticals said that it has received tentative approval from the US health regulator for Clindamycin Phosphate Foam, used to treat acne. The approved product is a generic version of Mylan Pharmaceuticals’ Evoclin Foam.
Glenmark Pharmaceuticals, USA, has been granted tentative approval by the United States Food and Drug Administration (US FDA) for Clindamycin Phosphate Foam, 1 per cent, the company said in a BSE filing.
For the 12 months to April 2019, Evoclin Foam market achieved annual sales of approximately USD 17 million, Glenmark said, citing IQVIA sales data.
The company’s current portfolio consists of 156 products authorised for distribution at the US marketplace and 59 Abbreviated New Drug Applications (ANDAs) pending approval with the US FDA.