Reuters logo
BRIEF-Antares Pharma receives complete response letter from FDA for Xyosted
October 20, 2017 / 10:53 PM / a month ago

BRIEF-Antares Pharma receives complete response letter from FDA for Xyosted

Oct 20 (Reuters) - Antares Pharma Inc

* Antares pharma receives complete response letter from the fda for Xyosted

* ‍CRL indicates that FDA cannot approve NDA in its present form​

* ‍FDA is concerned that Xyosted could cause a clinically meaningful increase in blood pressure​

* ‍CRL identified two deficiencies related to clinical data for Xyosted injection​

* Complete response ‍letter also raised a concern regarding occurrence of depression and suicidality​ 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