Alembic Pharmaceuticals receives USFDA approval for Tretinoin Cream USP, 0.05%

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tretinoin Cream USP, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.05%, of Bausch Health US, LLC. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris.

Tretinoin Cream USP, 0.05%, has an estimated market size of US$ 76 million for twelve months ending March 2026 according to IQVIA.