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Nicox resubmits NDA for AC-170

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Nicox has resubmitted a new drug application for AC-170, its eye drop formulation to treat ocular itching associated with allergic conjunctivitis, according to a company press release.

Branded as Zerviate, AC-170 (cetirizine ophthalmic solution 0.24%) was initially submitted in April 2016, but the company received a complete response letter from the FDA in October citing inspection issues with a third-party production facility.

Those Current Good Manufacturing Practice concerns have been resolved, according to the release.

The FDA has 30 days to acknowledge receipt of the NDA and a maximum review period of 6 months for a Class 2 resubmission.