US FDA sets PDUFA date for Zerviate review

The US Food and Drug Administration has set a Prescription Drug User Fee Act (PDUFA) date of September 8, 2017 for its decision on the New Drug Application for Zerviate (cetirizine ophthalmic solution) 0.24%.

The product is French ophthalmic R&D company Nicox’ (Euronext Paris: COX) novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis. Approval of the Zerviate NDA on or before December 1, 2017 would trigger a milestone payment in Nicox shares equivalent to $6.8 million. Cetirizineis the active ingredient of Zyrtec, marketed by Belgium’s UCB.

NicOx’ initial application was rebuffed last year, due to a failure of the manufacturing facility to meet current Good Manufacturing Practices. The NDA was resubmitted in March this year, when the French firm said it has received confirmation its API manufacturing site now meets industry standards.