7 August 2017 - Valeant Pharmaceuticals today announced it has received a complete response letter from the U.S. FDA regarding the new drug application for latanoprostene bunod ophthalmic solution, 0.024%, an investigative intra-ocular pressure lowering single-agent eye drop for patients with open-angle glaucoma or ocular hypertension.

The CRL from the FDA only refers to a Current Good Manufacturing Practice inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida. The FDA did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the application for latanoprostene bunod ophthalmic solution, 0.024%.

Valeant will work closely with the FDA to determine the appropriate next steps for the application.

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