Thursday, 20 September 2018

Glenmark Pharma gets USFDA nod for skin treatment cream

14 May 2018 | News

The company’s current portfolio consists of 134 products authorised for distribution in the US marketplace and 61 abbreviated new drug applications (ANDA) pending approval with the USFDA.

Glenmark Pharmaceuticals has received final approval from the USFDA for the generic version of Temovate cream used to treat inflammation and itching.

“Glenmark Pharmaceuticals Inc., USA has been granted final approval by the USFDA for Clobetasol Propionate cream USP, 0.05%, the generic version of Temovate Cream, 0.05%, of Fougera Pharmaceuticals, the firm said in a BSE filing.

Citing IQVIA sales data, Glenmark said that the company achieved annual sales of approximately $118 million from Temovate cream. The company’s current portfolio consists of 134 products authorised for distribution in the US marketplace and 61 abbreviated new drug applications (ANDA) pending approval with the USFDA. Glenmark shares were trading 1.75 per cent lower at Rs 507 on the BSE.

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