The U.S. Food Drug Administration (FDA) approved Alembic’s generic acitretin formulation for severe psoriasis.
Acitretin is an oral retinoid.
The company announced final approval from the FDA for its Abbreviated New Drug Application (ANDA) Acitretin Capsules USP, 1 mg, 17.5mg, and 25mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Soriatane Capsules, 10mg, 17. 5mg, and 25mg, of Stiefel Laboratories, Inc. (Stiefel).
