USFDA nod to Alembic Pharma Acitretin capsules for severe psoriasis
Acitretin capsules are indicated for the treatment of severe psoriasis in adults.
Vadodara: Alembic Pharmaceuticals Limited has 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..
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 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.
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company.
Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
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