FDA Approves Alembic’s Generic for Allergic Conjunctivitis
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.