USFDA nod to Alembic Pharma Acitretin capsules for severe psoriasis
Acitretin capsules are indicated for the treatment of severe psoriasis in adults.
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-08-07 11:45 GMT | Update On 2024-08-07 11:45 GMT
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.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement/treatment or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2024 Minerva Medical Treatment Pvt Ltd