Tuesday, 19 June 2018

Lupin receives FDA approval for generic Temovate Ointment, 0.05%

09 May 2018 | News

Clobetasol Propionate Ointment USP, 0.05% had annual sales of approximately 120 million in the US

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

Lupin’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.

Clobetasol Propionate Ointment USP, 0.05% had annual sales of approximately 120 million in the US (IQVIA MAT January 2018).

 

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