Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U. S.
FDA) for Hydrocortisone Valerate Ointment USP, 0.2%, a generic version of Westcort1 Ointment, 0.2%, of Sun Pharmaceutical Industries, Inc. Glenmark has been granted a competitive generic therapy (CGT) designation for Hydrocortisone Valerate Ointment USP, 0.2%, therefore, with this approval, Glenmark is eligible for 180 days of CGT exclusivity upon commercialization. This is Glenmark's first granted CGT product approved by the FDA.
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