Apotex, Teva Pharmaceuticals USA, Aurobindo Pharma and Glenmark Pharmaceuticals have won FDA’s approval to market atomoxetine in multiple strengths to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.
“Today’s approvals mark an important step forward in bringing consumers additional treatments that have met the FDA’s rigorous standards,” said Kathleen Uhl, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Quickly bringing generics to market so patients have more options to treat their conditions is a top priority for the FDA.”
FDA said that ADHD is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development.