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Alembic Pharma Receives USFDA Final Approval for Difluprednate Ophthalmic Emulsion
Alembic Pharmaceuticals has secured final USFDA approval for Difluprednate Ophthalmic Emulsion, 0.05%, which is a generic version of Sandoz's Durezol. The product is used for treating inflammation and pain after ocular surgery and for endogenous anterior uveitis. This approval marks a continued expansion of the company's US product portfolio. With this addition, Alembic now holds a cumulative total of 233 USFDA approvals, including 213 final approvals.
Key Highlights
Received final USFDA approval for Difluprednate Ophthalmic Emulsion, 0.05%
Product is therapeutically equivalent to the reference listed drug Durezol by Sandoz Inc.
Indicated for ocular surgery inflammation and endogenous anterior uveitis
Company's cumulative USFDA approvals reach 233 (213 final and 20 tentative)
💼 Action for Investors
Investors should monitor the commercial launch and market share capture of this product in the US ophthalmic market. The steady stream of USFDA approvals remains a key driver for the company's international revenue growth.