Lupin receives U.S. FDA approval for Hydrocortisone Valerate Cream

Lupin Limited has announced that it has received approval for its Hydrocortisone Valerate Cream USP, 0.2% from the United States Food and Drug Administration (U.S. FDA).

Lupin’s Hydrocortisone Valerate Cream USP, 0.2%, is the generic version of Westcort® Cream, 0.2%, of Sun Pharmaceutical Industries, Inc. It is indicated for the relief of the Inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients. Hydrocortisone Valerate Cream USP, 0.2%, (RLD: Westcort®) had an annual sales of approximately USD 15 million in the US (IQVIA MAT March 2019).