Lupin Gets U.S. FDA Nod To Market Skin Ointment
Pharma major Lupin Ltd. said it has received the United States Food and Drug Administration '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 U.S. FDA is to market its generic Betamethasone Dipropionate ointment USP (augmented), 0.05 percent, 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 percent had an annual sales of around $22 million in the U.S.
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.
Shares of Lupin were trading at Rs 774.20 per scrip on the BSE, up 0.45 percent from the previous close.