Lupin gets USFDA nod for generic version of Diprolene Ointment

Betamethasone Dipropionate Ointment USP (Augmented), 0.05% is a generic version of Diprolene Ointment and will be manufactured at the company’s Pithampur (Unit 3) facility, Lupi said.

Mumbai: Pharma major Lupin Limited (Lupin) recently announced that it has received approval for its Betamethasone Dipropionate Ointment USP (Augmented), 0.05%, from the United States Food and Drug Administration (U.S. FDA).

The product is a generic equivalent of Diprolene Ointment, 0.05%, of Merck Sharp and Dohme Corp. It will be manufactured at Lupin’s Pithampur (Unit 3) facility, India.

Betamethasone Dipropionate Ointment USP (Augmented), 0.05%, is a corticosteroid 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 annual sales of approximately USD 22 million in the U.S. (IQVIA MAT September 2019).

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Mumbai-based Lupin develops and delivers a wide range of branded and generic formulations, biosimilar products and APIs globally. The Company is a significant player in Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds a global leadership position in the Anti-TB segment.

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