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