Announced Fri, 26 Jun · 19:10 IST
Alembic Pharma gets USFDA final approval for Dapsone Gel 5 percent
Compliance View source PDF
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AI summary
Alembic Pharmaceuticals received USFDA final approval for its ANDA Dapsone Gel, 5 percent, used for topical treatment of acne vulgaris. The product is therapeutically equivalent to Almirall's Aczone Gel. With this, Alembic now has 244 cumulative ANDA approvals from USFDA, including 224 final and 20 tentative approvals.
Likely market impact
Positive for US generics revenue. Adds another product to Alembic's growing US portfolio, reinforcing its USFDA pipeline strength.