The global biopharmaceutical company Shire has received approval from the FDA to begin selling INTUNIV", an extended release tablet that is used to treat ADHD in people ages 6 to 17 years old.

Once-daily INTUNIV is expected to be available in US pharmacies in November and will come in four dosage strengths (1mg, 2mg, 3mg, and 4mg).

INTUNIV will be marketed in the United States by the existing Shire ADHD sales team of nearly 600 representatives. INTUNIV is not a controlled substance and has no known potential for abuse or dependence. (Source: News-Medical.net)

The efficacy of INTUNIV was established in two separate, placebo-controlled, double-blind clinical trials in children ages 6 to 17 years. In both trials, significant reductions of ADHD symptoms were demonstrated in the patients taking INTUNIV. Improvements became statistically significant one to two weeks after INTUNIV was administered.

Labels: medications, FDA

Posted By: Aspen/CRC