Nicox resubmits eye drug after factory inspection
Ophthalmic drug developer NicOx (Euronext Paris: COX) has resubmitted its application to the US Food and Drug Administration for Zerviate (cetirizine ophthalmic solution) the company’s novel cetirizine eye drop formulation.
Since its initial application was rebuffed last year, the French firm says it has received confirmation its API manufacturing site now meets industry standards.
The failure of the manufacturing facility to meet current Good Manufacturing Practices was the sole reason given by the FDA for the issuance of a Complete Response Letter last October.
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