Alembic Pharmaceuticals announces USFDA Final Approval for Acitretin Capsules USP, 10 mg, 17.5 mg, and 25 mg

7th August 2024, Bengaluru: 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) 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). Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Refer label for a detailed indication.

Acitretin Capsules USP, 10 mg, 17.5 mg, and 25 mg have an estimated market size of US$ 21 million for twelve months ending June 2024 according to IQVIA.

Alembic has a cumulative total of 212 ANDA approvals (184 final approvals and 28 tentative approvals) from USFDA.