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Alembic Pharmaceuticals receives USFDA approval for Acitretin Capsules
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Acitretin Capsules USP, 10 mg, 17.5 mg, and 25 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Soriatane Capsules, 10 mg, 17.5 mg, and 25 mg, of Stiefel Laboratories, Inc. (Stiefel).