Alembic JV Aleor receives US FDA final approval for skin disorder gel

Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea

Alembic Pharmaceuticals Limited announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Metronidazole Gel USP, 1%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Metrogel Gel, 1%, of Galderma Laboratories LP (Galderma).

 Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. Aleor had previously received tentative approval for this ANDA.

Metronidazole Gel USP, 1% had an estimated market size of US$ 29 million for twelve months ending June 2021 according to IQVIA.  Alembic has a cumulative total of 149 ANDA approvals (132 final approvals and 17 tentative approvals) from US FDA.