NEW DELHI, May 11: Glenmark Pharmaceuticals said it has received final approval from the US health regulator for the generic version of Temovate cream used to treat inflammation and itching caused by a number of skin conditions.
“Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Clobetasol Propionate cream USP, 0.05%, the generic version of Temovate Cream, 0.05%, of Fougera Pharmaceuticals,” the company said in a BSE filing.
For the 12 months to March 2018, Temovate cream achieved annual sales of approximately USD 118 million, Glenmark said, citing IQVIA sales data.
The company’s current portfolio consists of 134 products authorised for distribution at the US marketplace and 61 abbreviated new drug applications (ANDA) pending approval with the USFDA.
(PTI)
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