Alembic gets USFDA nod for ointment to treat skin disease

Alembic Pharmaceuticals on Tuesday said its joint venture, Aleor Dermaceuticals has received approval from the US health regulator for its generic version of Temovate topical solution which is used to treat a variety of skin conditions.

The approval by the US Food and Drug Administration (USFDA) is for Clobetasol Propionate topical solution USP, 0.05 per cent, which is therapeutically equivalent to the reference listed drug product Temovate Topical Solution, 0.05 per cent, of Fougera Pharmaceuticals Inc, the company said in a regulatory filing.

The medicine is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp, it added.

Citing IQVIA, Alembic said Clobetasol Propionate topical solution USP, 0.05 per cent, has an estimated market size of USD 33 million for 12 months, ending December 2018.

Alembic said it has a cumulative total of 104 abbreviated new drug application (ANDA) approvals (92 final approvals and 12 tentative approvals) from USFDA.