FDA NDA Approval Letter to Shire PLC for ADHD Medication Intuniv
The U.S. Food and Drug Administration approved Intuniv, an extended release formulation of guanfacin as a pediatric treatment for attention
deficit/hyperactivity disorder (ADHD). Clinical trials found the medication was better than a placebo at relieving ADHD symptoms for 24 hours. The medication,
in dosage strengths of 1 mg, 2 mg, 3 mg, and 4 mg, will be available as of November 2009.
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