Nicox receives CRL from FDA for AC-170

The U.S. Food and Drug Administration has sent Nicox S.A. a Complete Response Letter (CRL) in regard to its AC-170 New Drug Application (NDA).

AC-170 is a novel, proprietary, cetirizine eye drop formulation that was developed to treat ocular itching linked to allergic conjunctivitis.

According to the FDA, Nicox received a CRL due to a Good Manufacturing Practice inspection of a third party facility that produced an active pharmaceutical ingredient cetirizine that was then turned over to the finished product’s manufacturer.

Nicox has yet to turn in data on the safety and effectiveness of AC-170 to the FDA that would permit the request for additional clinical or non-clinical testing that would lead to the approval of the NDA for the drug. The CRL also did not contain concerns for the facility in which the finished product is being manufactured.

Nicox has contacted various suppliers since receiving the CRL to evaluate the timeline of manufacturing the API in order to address the concerns by the FDA. The NDA for AC-170 will then be resubmitted by Nicox once the concerns have been addressed.