Reuters logo
2 months ago
CORRECTED-BRIEF-Sunovion's says FDA accepted for review resubmission of NDA for Sun-101/eflow
June 30, 2017 / 12:12 PM / 2 months ago

CORRECTED-BRIEF-Sunovion's says FDA accepted for review resubmission of NDA for Sun-101/eflow

(Corrects headline to say FDA has accepted for review the resubmission of NDA for Sun-101/eflow, not that FDA has approved NDA for the drug. Also corrects source to Sunovion Pharmaceuticals from Sumitomo Dainippon Pharma)

June 30 (Reuters) - Sunovion Pharmaceuticals Inc:

* Sunovion announces FDA acceptance for review of new drug application resubmission for Sun-101/eflow® (glycopyrrolate) for the treatment of chronic obstructive pulmonary disease (COPD)

* Expected action date by FDA under prescription drug user fee act (PDUFA) is December 15, 2017​‍​ Source text for Eikon: Further company coverage:

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