FDA Rejects Valeant’s Marketing Application for IOP Eye Drop Latanoprostene Bunod

Source: Valeant

In a complete response letter (CRL) to Valeant, the FDA did not approve the new drug application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, citing Current Good Manufacturing Practice (CGMP) issues observed during an on-site inspection at subsidiary Bausch + Lomb's manufacturing facility in Tampa.

Latanoprostene bunod is an investigative IOP-lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension.

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 NDA for latanoprostene bunod ophthalmic solution, 0.024%.

Valeant said it will work closely with the FDA to determine the appropriate next steps for the NDA.

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