Vadodara: Alembic Pharmaceuticals Limited today announced that the company's joint venture Aleor Dermaceuticals Limited 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. 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 % 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.
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat.