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Home » Sanofi Gets Untitled Letter for Taxotere Journal Reprint Carrier
Sanofi Gets Untitled Letter for Taxotere Journal Reprint Carrier
May 15, 2009
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.
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