July 22, 2016 / 7:22 AM / a year ago

BRIEF-FDA to inspect Nicox partner Bausch + Lomb

1 Min Read

July 22 (Reuters) - Nicox SA :

* Has been informed by its partner Bausch + Lomb, a Valeant unit, of receipt of a complete response letter from U.S. FDA concerning latanoprostene bunod

* FDA's letter did not identify any efficacy or safety concerns with respect to NDA or additional clinical trials needed for approval of NDA for latanoprostene bunod ophthalmic solution, 0.024 pct

* Concerns raised by the FDA pertain to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida

* Some deficiencies were identified by the FDA at the Tampa plant

* Valeant intends to meet with FDA as soon as possible to work on a resolution and address these concerns Source text for Eikon: Further company coverage: (Gdynia Newsroom)

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