Lupin gets FDA OK for generic Diprolene

Lupin has received the Food and Drug Administration’s clearance for betamethasone dipropionate ointment in a dosage strength of  0.05%.

The product is the generic of Merck Sharp and Dohme’s Diprolene ointment, 0.05%.

Betamethasone dipropionate ointment, 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.

The product had a market value of approximately $22 million, according to IQVIA September 2019 data.

It will be manufactured at Lupin's Pithampur facility in India.