February 03, 2009
DDMAC sent a warning letter to Abbott requesting that the company cease dissemination of promotional Depakote and Depakote ER flashcards. According to the letter, posted to the FDA website on January 29, DDMAC found the flashcards to be misleading based on an omission of risk information and a broadened indication of Depakote ER, among other things.
Indevus Pharmaceuticals received a warning letter from DDMAC on January 27 regarding a journal ad for the overactive bladder drug Sanctura. DDMAC requested that that company immediately cease dissemination of the violative ad, based on false or misleading superiority claims, omissions and minimized material risk information, and an overstated efficacy of Sanctura.