Reuters logo
BRIEF-Lundbeck, Takeda receive CRL from FDA for Trintellix (vortioxetine) sNDA
June 23, 2017 / 12:39 AM / 3 months ago

BRIEF-Lundbeck, Takeda receive CRL from FDA for Trintellix (vortioxetine) sNDA

June 22 (Reuters) - Lundbeck

* Lundbeck and Takeda receive complete response letter from the FDA for Trintellix® (vortioxetine) sNDA

* CRL does not change FDA-approved current prescribing information for trintellix

* Lundbeck says S.S. FDA issued CRL regarding sNDA to include new data in clinical trials section of S.S. Prescribing information of trintellix (vortioxetine)

* Lundbeck says Takeda and Lundbeck are disappointed, but believe in strength of data and plan to continue discussions with fda on potential paths forward 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