Drug firm Glenmark Pharmaceuticals Monday said it has received final nod from the US health regulator for generic Hydrocortisone Valerate cream used for providing relief in inflammation and itching due to various skin conditions.
Glenmark Pharmaceuticals Inc has been granted final approval by the United States Food & Drug Administration (USFDA) for Hydrocortisone Valerate Cream USP, 0.2 per cent, Glenmark said in a statement.
The product is a generic version of Sun Pharmaceutical Industries Inc’s Westcort Cream in the same strength, it added.
According to IQVIA sales data for the 12-month period ending August 2018, the Westcort Cream, 0.2 per cent market achieved annual sales of around USD 17 million, Glenmark said.
The company’s current portfolio consists of 139 products authorised for distribution in the US marketplace and 60 abbreviated new drug applications (ANDA’s) pending approval with the USFDA, Glenmark said.
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