Aleor Dermaceuticals gets USFDA nod for generic antibacterial gel

New Delhi: Drug firm Alembic Pharmaceuticals on Monday said its joint venture Aleor Dermaceuticals has received approval from the US health regulator for generic use of Metronidazole gel in treatment of inflammatory lesions of rosacea. The company has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Metronidazole gel USP, 1 per cent, the Pharma company said.

The product is a generic version of Galderma Laboratories LP's Metrogel gel, 1 per cent, it added. According to IQVIA, Metronidazole Gel, USP 1 per cent, has an estimated market size of $29 million for twelve months ending June 2021. The product is indicated for the topical treatment of inflammatory lesions of rosacea. Aleor had previously received tentative approval for this ANDA, it added. The company has a cumulative total of 149 ANDA approvals (132 final approvals and 17 tentative approvals) from USFDA, the pharma company added.