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FDA Says Intuniv Promotional Materials are 'Misleading'

ROCKVILLE, Md., July 2, 2010--The FDA has posted on its website a review of materials from Shire for its ADHD drug Intuniv. The agency said in the review, "These promotional materials are false or misleading because they present unsubstantiated effectiveness claims, omit and minimize important risk information associated with Intuniv and present unsubstantiated superiority claims."

 

DDMAC Letter 

Promotional Material

Posted: July 2010


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