Lupin receives USFDA approval for generic Temovate Ointment

07 May 2018 Evaluate

Lupin has received final approval for its Clobetasol Propionate Ointment USP, 0.05% from the United States Food and Drug Administration (USFDA) to market a generic version of Fougera Pharmaceuticals Inc.’s Temovate Ointment, 0.05%. Clobetasol Propionate Ointment USP, 0.05% had annual sales of approximately 120 million in the US (IQVIA MAT January 2018).

The company’s Clobetasol Propionate Ointment USP, 0.05% is the AB rated generic equivalent of Fougera Pharmaceuticals Inc.’s Temovate Ointment, 0.05%. It is indicated for 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.

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