Athena Neurosciences Zanaflex
Executive Summary
Luncheon and dinner discussions held by Athena during the September meeting of the American Academy of Cerebral Palsy and Developmental Medicine represented promotions of Zanaflex (tizanidine) for the unapproved indication of spasticity in pediatric patients, FDA told the company. In response to a Sept. 23 letter from the agency, Athena maintained that the purpose of the program was to elicit discussion from physicians on whether to seek approval for Zanaflex for that indication. "However, upon examination of the materials and Athena's response, DDMAC found that the Athena-sponsored programs did not fill this need," the agency said. "Instead of attempting to answer the question of whether Athena should seek approval for Zanaflex in the pediatric population, [the moderator] provided the 'answer' and described how to use Zanaflex in children"
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