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Glenmark Pharmaceuticals has received final approval from the US health regulator to market Hydrocortisone Valerate ointment, used to treat a variety of skin conditions.
The nod has been granted by the United States Food and Drug Administration (USFDA) for Hydrocortisone Valerate Ointment USP, 0.2 per cent, a generic version of Westcort Ointment, 0.2 per cent, of Sun Pharmaceutical Industries Inc, the company said in a BSE filing.
Quoting IQVIA sales data for the 12-month period ended October 2018, the company said Westcort Ointment achieved annual sales of USD 11.1 million.
Glenmark said it is eligible for 180 days of competitive generic therapy (CGT) exclusivity upon commercialisation.
The company’s current portfolio consists of 145 products authorised for distribution in the US market, and 55 abbreviated new drug applications (ANDAs) are pending approval with the USFDA, it added.
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