November 24, 2015 / 5:05 PM / 4 years ago

BRIEF-Indivior says received a complete response letter from FDA on naloxone nasal spray

Nov 24 (Reuters) - Indivior Plc :

* Announced that it has received a complete response letter from U.S. Food and drug administration (FDA) regarding its new drug application for naloxone nasal spray

* Response was principally focused on clinical pharmacology that found early stage uptake of naloxone nasal spray did not fully meet FDA’s threshold as determined by reference product

* Indivior is evaluating FDA’s comments to determine next steps to address FDA’s findings Source text for Eikon: Further company coverage: (Bengaluru Newsroom: +91 80 6749 1136)

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