Lupin receives FDA nod for two generics
Lupin has received the Food and Drug Administration’s approval for its hydrocortisone butyrate lotion 0.1%
The product, which is a generic version of PreCision Dermatology’s PreCision Locoid lotion 0.1%, is a corticosteroid indicated for the topical treatment of mild-to-moderate atopic dermatitis in patients 3 months old and older.
Hydrocortisone butyrate lotion 0.1% has a market value of approximately $13.8 million in the United States, according to IQVIA April 2018 data.
In a separate development, Lupin announced it has received the FDA’s blessing for clobetasol propionate cream 0.05%.
Lupin’s clobetasol propionate cream 0.05% is the generic equivalent of Fougera Pharmaceuticals’s Temovate cream 0.05%. It is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Clobetasol propionate cream 0.05% has a market value of approximately $108.6 million in the United States, according to June 2018 IQVIA data.