IBEF: December 23, 2019
On Friday, Pharma major, Lupin, stated that it has received the USFDA's approval to market its Betmethasone Dipropionate ointment (augmented), in the American market.
Lupin also said in a filling to the BSE that the product will be manufactured at the company's Pithampur, Unit 3 facility. 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, the company said.
As per IQVIA MAT September 2019 data, Betamethasone Dipropionate ointment USP Augmented, 0.05 per cent had an annual sale of around US$ 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.
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