Aleor Dermaceuticals gets tentative USFDA nod for Efinaconazole topical solution

Drug firm Alembic Pharmaceuticals on Thursday said its joint venture firm Aleor Dermaceuticals has received tentative approval from the US health regulator for Efinaconazole topical solution, used in the treatment of fungal toenail infections.

The tentatively approved product is therapeutically equivalent to the reference listed drug product Jublia topical solution, 10 per cent, of Bausch Health Americas.

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Aleor Dermaceuticals has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Efinaconazole topical solution, 10 per cent, Alembic Pharma said in a regulatory filing.

The solution is indicated for the topical treatment of onychomycosis of the toenails.

Quoting IQVIA data, Alembic Pharma said Efinaconazole topical solution, 10 per cent, has an estimated market size of $233 million for the 12 months ending December 2020.

Alembic has a total of 140 ANDA approvals (123 final approvals and 17 tentative approvals) from USFDA.