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