Alembic Pharmaceuticals today announced that its joint venture Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Metronidazole gel USP, 1%.
In a statement, the company said that the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Metrogel gel, 1%, of Galderma Laboratories. Metronidazole gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea.
Aleor had previously received tentative approval for this ANDA, the statement said.
Metronidazole gel USP, 1% has an estimated market size of $29 million for twelve months ending June 2021, according to IQVIA, mentioned the statement.