Alembic says Aleor JV gets final FDA approval for Metronidazole Gel USP, 1 %

Alembic Pharmaceuticals said that its joint venture Aleor Dermaceuticals has secured final approval for Metronidazole Gel USP, 1 % from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA).

According to Alembic Pharmaceuticals, the approved ANDA is the therapeutical equivalent to the reference listed drug product (RLD) — Metrogel Gel, 1 %, of Galderma Laboratories.

Metronidazole Gel USP, 1 % is used for the topical treatment of inflammatory lesions of rosacea. Previously, Alembic Pharmaceuticals had been granted tentative approval for this ANDA.

As per IQVIA, for the 12 months ending June 2021, Metronidazole Gel USP, 1 % has an estimated market size of $29 million.

Alembic Pharmaceuticals has a total of 149 ANDA approvals, which include132 final approvals and 17 tentative approvals from the FDA.