Valeant Receives FDA Complete Response Letter for Vyzulta

August 11, 2017: By Jon Swedien

1 Ophthalmic NewsValeant Pharmaceuticals International has received a complete response letter (CRL) from the US FDA in response to its new drug application (NDA) for Vyzulta, the Canadian company announced Aug. 7.

Vyzulta (latanoprostene bunod ophthalmic solution 0.024%) is a nitric oxide-donating prostaglandin analog intended to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

According to Valeant, the CRL references a current good manufacturing practice (CGMP) inspection at a Tampa, Florida, manufacturing facility belonging to its Bausch + Lomb subsidiary.

The company said the FDA did not identify any efficacy or safety concerns or request additional clinical trials for NDA approval.

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

The US FDA had set a target action date of Aug. 24, 2017, for its decision on Vyzulta.

Bausch + Lomb and Nicox are co-developing the drug candidate. The two companies had resubmitted the NDA in early March after addressing concerns the FDA raised in a 2016 inspection of the Tampa facility.

Bausch + Lomb licensed the product candidate from Nicox in March 2010 and rebranded the drug Vyzulta in January. It was previously branded Vesneo.

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