BioCentury
ARTICLE | Clinical News

Cetirizine regulatory update

October 17, 2016 7:00 AM UTC

FDA issued a complete response letter to Nicox 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. ...