Glenmark Pharma has received the final approval from the US health regulator for its cream used for the treatment of fungal skin infections.
“Glenmark Pharmaceuticals Inc, USA has been granted a final approval by the United States Food & Drug Administration (USFDA) for Clotrimazole and Betamethasone Dipropionate cream USP, 1%|0.05%,” the company said in a statement.
The product is a generic version of Merck, Sharp and Dohme Corporation’s Lotrisone cream in the same strength, it added.
According to IMS Health sales data for the 12-month period ending September 2015, the Lotrisone cream USP 1%|0.05% brand and all available therapeutic equivalents achieved annual sales of approximately $82.4 million (nearly Rs 558.8 crore), Glenmark said.
Lotrisone cream is used for fungal infections that are inflamed and have symptoms of redness or itching.
The company’s current portfolio consists of 103 products authorised for distribution in the US marketplace and 63 abbreviated new drug application’s (ANDA’s) pending approval with the USFDA, Glenmark said.
Glenmark Pharma stock was trading at Rs 955.55 per scrip, down 0.56% from its previous close on the BSE.