New Delhi: Glenmark Pharmaceuticals has received final approval from the US health regulator for a generic version of Temovate Topical Solution used to treat certain scalp and skin conditions.
“Glenmark Pharmaceuticals USA has been granted final approval by the US Food and Drug Administration (USFDA) for Clobetasol Propionate Topical Solution USP, 0.05%,” the company said in a BSE filing.
The approved product is the generic version of Temovate Topical Solution, 0.05%.
For the 12 months period ending February 2018, Temovate Topical Solution, 0.05%, achieved annual sales of approximately $46.2 million, Glenmark said, citing IQVIA sales data. Glenmark said this product will be manufactured at its Baddi plant.
The company’s current portfolio consists of 133 products authorized for distribution at the US marketplace and 60 abbreviated new drug applications (ANDA) pending approval with the USFDA.