Reuters logo
3 months ago
BRIEF-Sumitomo Dainippon Pharma unit receives Complete Response Letter from FDA for SUN-101/eFlow® New Drug Application for chronic obstructive pulmonary disease
May 29, 2017 / 2:49 AM / 3 months ago

BRIEF-Sumitomo Dainippon Pharma unit receives Complete Response Letter from FDA for SUN-101/eFlow® New Drug Application for chronic obstructive pulmonary disease

May 29(Reuters) - Sumitomo Dainippon Pharma Co Ltd

* Says its US-based unit Sunovion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for SUN-101/eFlow®(glycopyrrolate) for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD),including chronic bronchitis and/or emphysema, on May 26 (US Eastern time)

* Says the CRL does not require unit to conduct any additional clinical studies for the approval of SUN-101/eFlow®

Source text in Japanese: goo.gl/GoQObR

Further company coverage: (Beijing Headline News)

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