New Delhi : Glenmark Pharmaceuticals has received final nod from the US health regulator for generic Triamcinolone acetonide cream used for reducing itching, redness and swelling on skin.
Company’s US subsidiary “Glenmark Pharmaceuticals Inc has been granted final approval by the United States Food and Drug Administration (USFDA) for Triamcinolone acetonide cream USP, 0.1 per cent,” Glenmark said in a BSE filing.
The product is generic version of Delcor Asset Corporation’s Kenalog cream in the same strength, it added.
According to IMS Health sales data for the 12-month period ended June 2016, the Kenalog cream, 0.1 per cent market (includes brand and all available therapeutic equivalents) achieved annual sales of approximately USD 43.6 million, Glenmark said.
Company’s current portfolio consists of 108 products authorised for distribution in the US marketplace and 61 abbreviated new drug applications (ANDA’s) pending approval with the USFDA, it added.
Shares of Glenmark Pharmaceuticals were trading 1.32 per cent up at Rs 854.00 on BSE.