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+--- Thread: Alembic Pharma Secures Final USFDA Approval for Acitretin Capsules USP (/thread-550.html)
Alembic Pharma Secures Final USFDA Approval for Acitretin Capsules USP - Sapna Mukherjee - 09-08-2024
Alembic Pharma Secures Final USFDA Approval for Acitretin Capsules USP
Alembic Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Acitretin Capsules USP. This approved ANDA is considered therapeutically equivalent to the reference listed drug product, Soriatane Capsules, by Stiefel Laboratories, Inc.
Acitretin capsules are prescribed for the treatment of severe psoriasis in adults, a chronic skin condition. The drug has a significant market potential, with an estimated market size of USD 21 million (approximately INR 176 crore) for the twelve months ending June 2024, according to data from IQVIA.
This approval allows Alembic Pharma to produce and market Acitretin Capsules USP in the U.S., contributing to the company's portfolio of dermatological solutions. The achievement marks another milestone for Alembic Pharma in its ongoing efforts to expand its product offerings in the global pharmaceutical market.