Alembic receives USFDA final approval for Tretinoin Cream USP, 0.05%
ANDA approved for Tretinoin Cream USP, 0.05%, referencing Retin-A Cream, 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 per cent.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.05 per cent, of Bausch Health US, LLC. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. Refer label for a detailed indication.
Tretinoin Cream USP, 0.05 per cent, has an estimated market size of US$ 76 million for twelve months ending March 2026 according to IQVIA.
Alembic has a cumulative total of 242 ANDA approvals (222 final approvals and 20 tentative approvals) from USFDA.