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# FDA Rejects Nicox NDA for Conjunctivitis Drug
- URL: https://www.fdaweb.com/fda-rejects-nicox-nda-for-conjunctivitis-drug/
- Published: 2016-10-10T12:00:00.000Z
- Updated: 2026-09-14T21:38:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137043

FDA has sent Nicox a complete response letter (CRL) on its NDA for AC-170 (cetirizine), an eye drop formulation for treating ocular itching associated with allergic conjunctivitis. The letter cited a GMP inspection at a third party facility producing the active pharmaceutical ingredient as the reason for not approving the submission, according to the company. “The safety and efficacy data submitted by Nicox in the AC-170 NDA have not resulted in the FDA requesting any further clinical or non-clinical testing for the approval of the AC-170 NDA,” it says. “Since the receipt of the CRL, Nicox has been contacting its suppliers to assess the timeline for the API manufacturer to address the FDA’s concerns. Once these have been addressed, Nicox will then resubmit the AC-170 NDA.”

Nicox says that the formulation of cetirizine, which is the active ingredient in McNeil Consumer Healthcare’s Zyrtec, has been developed for the first time for topical application. Two Phase 3 safety and efficacy trials demonstrated statistically significant results for AC-170 compared to vehicle control (placebo) for the primary endpoint of ocular itching, according to the company.