Alembic Pharma gets tentative USFDA nod for Efinaconazole tropical solution

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

The solution is indicated for the tropical treatment on onychomycosis of the toenails. The tentatively approved product is therapeutically equivalent to the reference listed drug product Jubila tropical solution, 10%, of Bausch Health Americas.