Sanofi Gets Untitled Letter for Taxotere Journal Reprint Carrier

The FDA cited Sanofi-Aventis for making unsubstantiated superiority claims for its breast cancer chemotherapy Taxotere in a professional journal reprint carrier distributed at the American Society of Clinical Oncology annual meeting last June. The claims made by the company referenced a reprint from the Journal of Clinical Oncology. The reprint carrier made multiple superiority claims based on a study that did not meet its primary endpoint — statistically significant objective response rates for Taxotere (docetaxel) compared with paclitaxel, an untitled letter says.
Drug Industry Daily