Novartis’ Menveo Advertising Spurs FDA Untitled Letter

Novartis Vaccines and Diagnostics has received an FDA untitled letter for audio advertising of its Menveo meningococcal vaccine. An audio news release submitted under Form 2253 for FDA review by Novartis minimizes risks associated with Menveo (meningococcal [groups A, C, Y, and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine), which include the potential for an increased risk of Guillain-Barre syndrome, according to the May 7 letter, posted recently on the CBER website.
Washington Drug Letter