logo
Share SHARE
FONT-SIZE Plus   Neg

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

Novartis (NVS: Quote) 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

Editors Pick
H&R Block, Inc., the largest U.S. tax preparer, said Wednesday after the markets closed that its third quarter loss narrowed sharply from last year, as revenue surged due to an earlier opening of the Internal Revenue Service's e-file system this tax season. The company's quarterly loss per share also smaller than analysts estimated, but its quarterly revenue fell short of analysts' forecast. Microsoft co-founder Paul Allen's maritime plunge took an exciting yet somber turn, after he found the wreck of a once-feared World War II Japanese battleship that met its doom by enemy torpedoes decades ago near the Philippines. A new study reveals that more large companies in the U.S. are run by men with the names John, Robert, William or James than the total number of women CEOs. For each women CEO of S&P 1500 companies there are four men CEOs named John, Robert, William or James, according to a study conducted by the New...
comments powered by Disqus
RELATED NEWS
Trade NVS now with 
Follow RTT