Alembic Pharmaceuticals gets USFDA’s final approval for Acitretin Capsules

07 Aug 2024 Evaluate

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). Acitretin capsules are indicated for the treatment of severe psoriasis in adults.

Acitretin Capsules USP, 10 mg, 17.5 mg, and 25 mg have an estimated market size of $21 million for twelve months ending June 2024 according to IQVIA. The company has a cumulative total of 212 ANDA approvals (184 final approvals and 28 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.


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