PTI Dec 20, 2019, 03.27 PM IST
Pharma major Lupin on Friday said it has received the USFDA's approval to market its Betamethasone Dipropionate ointment (augmented), in the American market.
The product will be manufactured at the company's Pithampur, Unit 3 facility, Lupin said in a filing to the BSE.
The approval by the United States Food and Drug Administration (USFDA) is to market its generic Betamethasone Dipropionate ointment USP (augmented), 0.05 per cent, it added.
The product is a generic version of Merck Sharp and Dohme Corp's Diprolene ointment in the same strength, Lupin said.
As per IQVIA MAT September 2019 data, Betamethasone Dipropionate ointment USP Augmented, 0.05 per cent had an annual sales of around USD 22 million in the US.
The ointment 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 it added.