Menactra Label Does Not Allow For Comparative Claims, FDA Says
This article was originally published in The Pink Sheet Daily
Labeling for Sanofi-Aventis' Menactra does not allow for superiority claims, FDA said in its Jan. 14 approval letter for the meningococcal conjugate vaccine
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FDA approves the meningococcal conjugate vaccine for patients 11-55 years old; Sanofi-Aventis will submit a sBLA for use in children ages 2-11 by February. The company is currently studying the vaccine in patients under age 2 and will initiate a study evaluating Menactra in subjects over age 55 years by January 2006.
A possible settlement between Merck and tax authorities could be significantly smaller than GlaxoSmithKline's recent settlement with the IRS based on the companies' projected liability