Nicox announces PDUFA date for Zerviate NDA

Nicox announces PDUFA date for Zerviate NDA

April 11, 2017 Off By Dino Mustafić

U.S. Food and Drug Administration (FDA) has set a PDUFA date of September 8, 2017 for its decision on the New Drug Application (NDA) for Nicox’s Zerviate (cetirizine ophthalmic solution) 0.24%.

Zerviate is Nicox`s novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis, the company explained in its press release.

Michele Garufi, Chairman and Chief Executive Officer of Nicox, commented: “The FDA`s acknowledgement regarding the completeness of the NDA resubmission for Zerviate and the assignment of a PDUFA goal date of September 8, 2017 are important milestones for Nicox. Together with the August 24, 2017 PDUFA goal date for Vyzulta(TM), licensed to Bausch + Lomb (a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc.), we now await two approval decisions from FDA during the next 6 months for our lead programs, both of which are expected to be sources of significant recurrent revenue for the Company. For Zerviate , we will continue to work closely with the FDA toward an approval decision in September, and advance our partnering discussions for U.S. commercialization rights which are already underway.”

To remind, Nicox resubmitted the NDA for Zerviate on March 8, 2017, in reply to a Complete Response Letter (CRL) received from the U.S. FDA in October 2016. The FDA`s stated reason for the CRL pertained solely to a CGMP inspection at a third party facility producing the active pharmaceutical ingredient (API), cetirizine, and supplying it to the manufacturer of the finished product. The FDA`s Current Good Manufacturing Practice (CGMP) concerns surrounding the production site of the active pharmaceutical ingredient (API), cetirizine, have been resolved, said the company.