FDA warns Shire about overstating benefits of ADHD drug Intuniv

06/30/2010 | Bloomberg Businessweek

The FDA sent a warning letter to Shire saying that promotional materials for Intuniv, an extended-release drug for attention-deficit/hyperactivity disorder, present "unsubstantiated effectiveness claims" and "omit and minimize important risk information." A Shire spokesman said the company is "reviewing information and working closely with the FDA in order to update the materials with the correct information."

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