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)