ASCO advertising letters continue
Executive Summary
FDA ad division letters cites Aventis for Taxotere (docetaxel) promotional brochure describing an unapproved indication and SkyePharma/Chiron for solicitation of off-label information requests for DepoCyt at the American Society of Clinical Oncology meeting in May. FDA has issued at least 11 letters regarding promotions at the meeting (1"The Pink Sheet" Aug. 6, p. 6)
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Bristol-Myers Squibb UFT
FDA ad division objects to Bristol's dissemination of safety and efficacy data for UFT (uracil and tegafur) at ASCO in July 20 letter. "It is particularly concerning that BMS promoted this investigational drug as safe or effective in light of the fact that they received a 'not approvable' letter from the FDA in March of this year," the agency said (1"The Pink Sheet" April 2, In Brief). The ad division has issued at least nine letters regarding promotions at the May ASCO meeting (2"The Pink Sheet" July 30, p. 11)