Reuters logo
BRIEF-Nicox receives complete response letter from FDA for AC-170
October 10, 2016 / 5:51 AM / a year ago

BRIEF-Nicox receives complete response letter from FDA for AC-170

Oct 10 (Reuters) - Nicox SA :

* Receives complete response letter from FDA related to GMP on NDA for AC-170

* FDA’s stated reason for CRL pertains to good manufacturing practice inspection at a third party facility producing API cetirizine and supplying it to manufacturer of finished product

* Safety and efficacy data submitted by Nicox in AC-170 NDA have not resulted in FDA requesting any further clinical or non-clinical testing for approval Source text for Eikon: Further company coverage: (Gdynia Newsroom)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below