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ARTICLE | Company News

Nicox's eye drop gets complete response letter

October 10, 2016 7:00 AM UTC

Nicox S.A. (Euronext:COX) received a complete response letter from FDA for AC-170 to treat ocular itching associated with allergic conjunctivitis. The company said the letter related "solely" to a GMP inspection at a third party facility producing AC-170's API, cetirizine.

Nicox said it plans to resubmit the NDA after the API manufacturer addresses FDA's concerns, but Nicox did not provide a timeline. ...