July 1, 2009 / 5:33 AM / in 9 years

Novartis says FDA wants more information on Menveo

* FDA seeks clinical, other data on meningitis vaccine

* Company says expects to provide full response in 2009

ZURICH, July 1 (Reuters) - Swiss pharmaceuticals company Novartis NOVN.VXsaid the U.S Food and Drug Administration (FDA) has asked for more information on procedures relating to its Menveo meningitis vaccine.

The U.S regulator requested additional information on the clinical and the Chemistry Manufacturing and Control sections of the licence application for the vaccine, part of the regulatory procedure, the group said on Wednesday. No new clinical trials are required for the vaccine, which is still under development, and Novartis expects to be able to respond to all questions fully in 2009, the Swiss group said.

Reporting by Martin de Sa'Pinto; editing by John Stonestreet

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