Glenmark Pharmaceuticals USA has received approval from the United States Food and Drug Administration (USFDA) for Clobetasol Propionate Ointment, used for the treatment of various skin conditions.
“Glenmark Pharmaceuticals Inc, USA has been granted final approval by the USFDA for Clobetasol Propionate Ointment USP, 0.05 per cent,” the company said in a BSE filing.
The approved product is a generic version of Fougera Pharmaceuticals Inc’s Temovate Ointment, 0.05 per cent.
As per IMS Health sales data for the 12-month period ended January 2017, the Temovate Ointment, 0.05 per cent achieved annual sales of approximately $175.3 million, the filing added.
Glenmark’s current portfolio consists of 113 products authorised for distribution in the US marketplace and approximately 64 ANDA’s pending approval with USFDA.
Shares of Glenmark Pharmaceuticals were trading 0.56 per cent higher at Rs 885.30 on the BSE.