Nicox to resubmit cetirizine NDA after manufacturing concerns are addressed

Nicox S.A. announced that it received a Complete Response Letter from the FDA regarding the New Drug Application for AC-170 as a result of an inspection at a third-party facility that produces the active pharmaceutical agent, cetirizine, and supplies it to the manufacturer of the finished product.AC-170 is Nicox’s novel, proprietary, cetirizine eye drop formulation for treating ocular itch associated with allergic conjunctivitis, according to a press release from the company.