Alembic Pharmaceuticals (Alembic) today announced that its joint venture Aleor Dermaceuticals (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 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.
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