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Valeant's eye drops rejected by US FDA

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Valeant's eye drops rejected by US FDA

The U.S. Food and Drug Administration rejected Valeant Pharmaceuticals International Inc.'s investigative eye drops for patients with open angle glaucoma or ocular hypertension.

The complete response letter for latanoprostene bunod ophthalmic solution only refers to a current good manufacturing practice inspection at a Bausch & Lomb facility in Tampa, Fla.

The letter did not identify any efficacy or safety issues with the application for the eye drops or additional clinical trials needed for the approval of the application.

Valeant said it will work closely with the agency to determine the suitable next steps for the application.