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
Facebook's Chief Operating Officer Sheryl Sandberg said the company would be a founding partner of Station F start-up garage in Paris. There will be more than 3000 desks for tech companies at the start-up garage. In its first ever start-up project, Facebook plans to have 80 desks and would initiate the activities by April. Book retailer Barnes & Noble has pulled off from shelves its Nook tablet due to a faulty charger, after launching the cheap 7-inch tablet in November to take on Amazon's popular Fire tablets. Nook tablet has been removed from brick and mortar stores as well from online. Barnes & Noble has not issued... Morgan Stanley (MS) reported fourth-quarter net income applicable to company of $1.7 billion, or $0.81 per share compared with income of $908 million, or $0.39 per share, for the same period a year ago. On average, 24 analysts polled by Thomson Reuters expected the company to report profit per share...
comments powered by Disqus
Follow RTT