BioCentury
ARTICLE | Company News

Priority Review for Nicox's eye drop

June 22, 2016 12:15 AM UTC

Nicox S.A. (Euronext:COX) said FDA accepted and granted Priority Review to an NDA for AC-170, the company's topical formulation of cetirizine, to treat ocular itching associated with allergic conjunctivitis. Its PDUFA date is Oct. 18.

Cetirizine is a histamine H1 receptor ( HRH1) antagonist. Nicox submitted the NDA under FDA's 505(b)(2) pathway, which allows sponsors to reference data on safety and efficacy from previously approved products. Cetirizine is the active ingredient in the antihistamine Zyrtec. ...