Lupin receives USFDA's approval for generic Temovate Cream

02 Feb 2018 Evaluate

Lupin has received final approval for its Clobetasol Propionate Cream USP, 0.05% from the United States Food and Drug Administration (USFDA) to market a generic version of Fougera Pharmaceuticals Inc.’s Temovate Cream, 0.05%. Clobetasol Propionate Cream USP, 0.05% had annual sales of around $135 million in the US. (IQVIA, erstwhile IMS, MAT October 2017).

Lupin’s Clobetasol Propionate Cream USP, 0.05% is the generic equivalent of Fougera Pharmaceuticals Inc.’s Temovate Cream, 0.05%. It is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.


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