FDA News

FDA responds to NDA for glaucoma drug

The FDA has sent a complete response letter to Valeant Pharmaceuticals regarding the new drug application for the Bausch + Lomb latanoprostene bunod ophthalmic solution 0.024% product called Vyzulta.

The investigational single-agent IOP-lowering eye drop is intended for treatment of open angle glaucoma or ocular hypertension.

The letter “only refers to a current good manufacturing practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Fla.,” and “did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA,” according to a press release from Valeant.

A PDUFA date for the product had been slated for Aug. 24.

The FDA has sent a complete response letter to Valeant Pharmaceuticals regarding the new drug application for the Bausch + Lomb latanoprostene bunod ophthalmic solution 0.024% product called Vyzulta.

The investigational single-agent IOP-lowering eye drop is intended for treatment of open angle glaucoma or ocular hypertension.

The letter “only refers to a current good manufacturing practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Fla.,” and “did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA,” according to a press release from Valeant.

A PDUFA date for the product had been slated for Aug. 24.