Home > Newsletters > FDAnews Drug Daily Bulletin > BMS Sales Aid for Cancer Drug Draws Untitled Letter for False Claims
FDAnews Drug Daily Bulletin
Aug. 2, 2012 | Vol. 9 No. 151
BMS Sales Aid for Cancer Drug Draws Untitled Letter for False Claims
Bristol-Myers Squibb (BMS) has received an untitled letter for a sales aid for breast cancer drug Ixempra that allegedly made unsupported efficacy claims and broadened the drug’s indication. The sales aid, which discusses the pivotal studies for Ixempra’s (ixabepilone) monotherapy and combination therapy indications, makes claims about clinical trial measurements that are not noted in the product’s prescribing information, the untitled letter states.
Washington Drug Letter
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.