Alembic Pharmaceuticals' JV Aleor Dermaceuticals receives USFDA nod for Efinaconazole Topical Solution

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Jublia Topical Solution, 10%, of Bausch Health Americas, Inc. (Bausch).

Apr 08, 2021 02:04 IST India Infoline News Service

Alembic Pharmaceuticals
Alembic Pharmaceuticals Limited (Alembic) has announced on Thursday that its joint venture Aleor Dermaceuticals Limited (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 US$ 233 million for twelve months ending December 2020 according to IQVIA. 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 was trading at Rs976.80 apiece up by Rs3.55 or 0.36% from its previous closing of Rs973.25 apiece on Sensex, at around 2:40 PM.

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