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Pharmaceuticals / Submissions and Approvals

FDA Approves Alembic’s Generic for Allergic Conjunctivitis

Dec. 19, 2018
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The FDA approved Alembic Pharmaceuticals’ ANDA for olopatadine hydrochloride ophthalmic solution for treatment of allergic conjunctivitis, deeming the generic product therapeutically equivalent to Novartis’ Patanol.

Patanol had estimated sales of $61 million for the twelve months ending December 2017.

This marks the company’s first approval for a drug in ophthalmic dosage form. Alembic currently has 83 ANDA approvals from the agency, according to the drugmaker.

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