The U.S. Food and Drug Administration approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.
Apotex Inc., Teva Pharmaceuticals USA Inc., Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited gained approval to market atomoxetine in multiple strengths.
"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."
Atomoxetine must be dispensed with a patient Medication Guide that describes the drug's uses and warnings. This medication has a boxed warning for the increased risk of suicidal ideation in children and adolescents.
