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FDA Approves INTUNIV® (guanfacine) Extended-Release Tablets for Use as Adjunctive Therapy to Stimulants for the Treatment of ADHD in Children and Adolescents
Date:2/28/2011

nd included syncope, mixed disturbance of emotions (similar to behaviors prior to study start), poison ivy, and a nonintentional overdose in a sibling of a study participant. All SAEs were considered by the investigator to be unrelated to INTUNIV.(2)

"This approval marks a significant development in our ADHD portfolio -- one that may help to address symptoms that many children with ADHD may experience while on stimulant treatment," said Michael Yasick, Senior Vice President of Shire's ADHD Business Unit. "We understand that every child is unique, and it is our goal to offer treatment options for ADHD in a variety of situations, whether a child could benefit from treatment with a stimulant, nonstimulant, or both."

About INTUNIV

INTUNIV is available in four doses -- 1 mg, 2 mg, 3 mg, and 4 mg.(1)  INTUNIV should be taken once a day.(1)  The active ingredient in INTUNIV is guanfacine. INTUNIV is not a central nervous system (CNS) stimulant or a controlled substance.(1)  It is not likely to cause dependence or be abused.(1)

IMPORTANT SAFETY INFORMATION

INTUNIV should not be used in patients with a history of hypersensitivity to guanfacine or any of its inactive ingredients or by patients taking other products containing guanfacine (eg, TENEX®).

Hypotension, bradycardia, and syncope were observed in clinical trials. Use INTUNIV with caution in treating patients who have experienced hypotension, heart block, bradycardia, or syncope, or who may have a condition that predisposes them to syncope; are treated concomitantly with antihypertensives or other drugs that can reduce blood pressure or heart rate or increase the risk of syncope. Heart rate and blood pressure should be measured prior to initiation of therapy, followin
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SOURCE Shire plc
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