FDAnews Drug Daily Bulletin

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