Wednesday, 19 December 2018

Lupin receives FDA approval for generic Temovate Cream, 0.05%

06 February 2018 | News

It is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses

Pharma major Lupin has announced that it has received final approval for its Clobetasol Propionate Cream USP, 0.05% from the United States Food and Drug Administration (FDA) to market a generic version of Fougera Pharmaceuticals Inc.’s Temovate Cream, 0.05%.

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.

Clobetasol Propionate Cream USP, 0.05% had annual sales of approximately USD 135 million in the US. (IQVIA, erstwhile IMS, MAT October 2017)

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