Aleor Dermaceuticals gets USFDA nod for generic antibacterial gel

NEW DELHI, Sept 6: Drug firm Alembic Pharmaceuticals on Monday said its joint venture Aleor Dermaceuticals has received approval from the US health regulator for generic Metronidazole gel, used in the treatment of inflammatory lesions of rosacea.
Aleor Dermaceuticals Ltd has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Metronidazole gel USP, 1 per cent, Alembic Pharma said in a regulatory filing.
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 USD 29 million for twelve months ending June 2021, Alembic Pharma said.
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, Alembic Pharma said.