USFDA Final Approval for Tretinoin Cream USP, 0.05%. - Alembic Ltd

Code BSE: 506235 NSE: $ALEMBICLTD Company has received US Food & Drug Administration (USFDA) Final Approval for Tretinoin Cream USP, 0.05%. Alembic Pharmaceuticals Limited (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. Refer label for a detailed indication.