Reuters logo
BRIEF-Insys Therapeutics' NDA For Buprenorphine Sublingual Spray Accepted By FDA
December 6, 2017 / 3:04 PM / 7 days ago

BRIEF-Insys Therapeutics' NDA For Buprenorphine Sublingual Spray Accepted By FDA

Dec 6 (Reuters) - Insys Therapeutics Inc:

* FDA ACCEPTS NEW DRUG APPLICATION (NDA) FOR BUPRENORPHINE SUBLINGUAL SPRAY FROM INSYS THERAPEUTICS

* SAYS ‍UNDER PDUFA, FDA HAS SET TARGET DATE OF JULY 28, 2018 TO COMPLETE REVIEW OF NDA FOR BUPRENORPHINE SUBLINGUAL SPRAY​

* SAYS ‍DATA FROM RECENTLY COMPLETED 7-DAY SAFETY & TOLERABILITY STUDY TO BE SUBMITTED TO FDA IN Q1 2018, MAY IMPACT PDUFA DATE​ Source text for Eikon: Further company coverage:

Our Standards:The Thomson Reuters Trust Principles.
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