The U.S. Food and Drug Administration (FDA) has approved Strattera (atomoxetine HCl), judging it safe and effective for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents and adults.
Strattera, developed by Eli Lilly and Company, is the first FDA-approved treatment for ADHD that is not a stimulant under the Controlled Substances Act. Having a noncontrolled option, such as Strattera, reduces prescription hassles for patients, families and physicians by offering the convenience of phone-in refills and samples.
"Strattera is an important development in the treatment of ADHD, and we are excited about its future," said Sidney Taurel, Lilly's chairman, president and chief executive officer. "It gives patients, families and physicians an effective new tool for treating this complicated disorder and illustrates Lilly's commitment to providing 'Answers That Matter.'"
"Strattera is the second product approval we have received from the FDA," Taurel said. "We are pleased to be delivering on the promise of our late-stage pipeline, which is generating new and important medicines for patients. Our innovation-driven strategy is positioning Lilly for strong long-term growth."
The approval came roughly three months after the FDA issued an approvable letter for Strattera. Lilly expects to have Strattera available in pharmacies in January.
ADHD affects 3-7 per cent of school age children, making it the most-commonly diagnosed behavioral disorder of childhood. It manifests itself in levels of attention, concentration, activity, distractibility and impulsivity that are inappropriate for the child's age. A growing body of evidence suggests a biological cause and a genetic link for the disorder, and experts estimate up to 60 per cent of children with the disorder continue to have symptoms as adults.