Lupin receives FDA nod for two generics

8/21/2018
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.
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