Reuters logo
BRIEF-U.S. FDA accepts for review Astellas' supplemental NDA for mirabegron for use in combination with solifenacin succinate
September 13, 2017 / 2:34 AM / 8 days ago

BRIEF-U.S. FDA accepts for review Astellas' supplemental NDA for mirabegron for use in combination with solifenacin succinate

Sept 12 (Reuters) - Astellas Pharma Inc

* U.S. FDA accepts for review Astellas’ supplemental New Drug Application for Mirabegron for use in combination with solifenacin succinate 5 mg for the treatment of overactive bladder

* Anticipated Prescription Drug User Fee Act (PDUFA) goal date for a decision by FDA is April 28, 2018 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