Alembic Pharmaceuticals Limited (Alembic) today announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received tentative 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 Indicated for the topical treatment of inflammatory lesions of rosacea.
Metronidazole Gel USP, 1 % has an estimated market size of US$ 32 million for twelve months ending December 2020 according to IQVIA.
Alembic has a cumulative total of 142 ANDA approvals (124 final approvals and 18 tentative approvals) from USFDA.