Lupin receives USFDA approval for Betamethasone Dipropionate Ointment USP

Lupin announced that it has received approval for its Betamethasone Dipropionate Ointment USP (Augmented), 0.05%, from the United States Food and Drug Administration (USFDA), to market a generic equivalent of Diprolene Ointment, 0.05%, of Merck Sharp and Dohme Corp. The product will be manufactured at Lupin's Pithampur (Unit 3) facility, India.

Betamethasone Dipropionate Ointment USP (Augmented), 0.05%, is a corticostero id indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older.

Betamethasone Dipropionate Ointment USP (Augmented), 0.05%, (RLD: Diprolene) had an annual sales of approximately USD 22 million in the U.S. (IQVIA MAT September 2019).

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