Alembic Pharmaceuticals’ JV gets tentative approval for Efinaconazole Topical Solution

08 Apr 2021

Alembic Pharmaceuticals’ joint venture (JV) -- Aleor Dermaceuticals (Aleor) has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Efinaconazole Topical Solution, 10%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Jublia Topical Solution, 10%, of Bausch Health Americas, Inc. (Bausch). Efinaconazole Topical Solution, 10% is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes. 

Efinaconazole Topical Solution, 10% has an estimated market size of $ 233 million for twelve months ending December 2020. Aleor has settled the case with Bausch Health and. will launch its generic as per the terms of settlement. Alembic has a cumulative total of 140 ANDA approvals (123 final approvals and 17 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

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