logo
Share SHARE
FONT-SIZE Plus   Neg

FDA Requests Addl. Data On Novartis' Menveo For Expanded Use In Infants,toddlers

Novartis (NVS) said it has received a Complete Response letter from the US Food and Drug Administration or FDA on its application for the expanded use of Menveo in infants and toddlers from 2 months of age.

Novartis submitted the supplemental Biologics License Application or sBLA for Menveo to the FDA in April 2011. The Complete Response letter indicated that the FDA has completed the current review cycle and requests answers to additional questions prior to proceeding with further review of the sBLA. Novartis would work with the FDA to address these questions.

Meningococcal Oligosaccharide Diphtheria CRM Conjugate Vaccine, Menveo, is already approved for use in individuals 2 to 55 years of age in the U.S.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Dealing a potentially fatal blow to a last-ditch effort by Republicans to repeal and replace Obamacare, Senator John McCain, R-Ariz., on Friday announced his opposition to a healthcare bill drafted by Senators Lindsey Graham, R-S.C., and Bill Cassidy, R-La. Reiterating his claim that Russian meddling in last year's election is a hoax, President Donald Trump has argued that the biggest influence on the election came from the media. Trump seemed to suggest in a post on Twitter on Friday that his victory in the presidential election came despite the media's... U.S. airlines collected a record $7.1 billion in revenue from fees for checked baggage and for changing or canceling reservations, reflecting a marked increase from 2010, according to a government report. The U.S. Government Accountability Office or GOA said in a report that U.S. airlines' revenue from these two fees increased to $7.1 billion in 2016 from $6.3 billion in 2010, in constant dollars.
comments powered by Disqus
Follow RTT