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Glenmark Pharmaceuticals receives ANDA approval for Hydrocortisone Valerate Ointment USP, 0.2 pc

Glenmark Pharmaceuticals receives ANDA approval for Hydrocortisone Valerate Ointment USP, 0.2 pc

Mumbai, Dec 17(UNI) Pharma major Glenmark Pharma said that Glenmark Pharmaceuticals Inc., US has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Hydrocortisone Valerate Ointment USP, 0.2 pc, a generic version of Westcort Ointment, 0.2 pc, of Sun Pharmaceutical Industries, Inc.

Glenmark has been granted a competitive generic therapy (CGT) designation for Hydrocortisone Valerate Ointment USP, 0.2 pc, therefore, with this approval, Glenmark is eligible for 180 days of CGT exclusivity upon commercialisation, Glenmark said in a filing with BSE.

This is Glenmark's first granted CGT product approved by the FDA.

According to IQVIATM sales data for the 12 month period ending October 2018, the Westcort Ointment, 0.2 pc market 2 achieved annual sales of approximately USD11.1 million.

Glenmark's current portfolio consists of 145 products authorized for distribution in the U.S. marketplace and 55 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

UNI JS NV JW1412

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