The US Food and Drug Administration (FDA) has 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 received approval to market atomoxetine in multiple strengths.
In clinical trials for atomoxetine in children and adolescents, the most common side-effects reported were upset stomach, decreased appetite, nausea or vomiting, dizziness, tiredness, and mood swings. In adults, side-effects included constipation, dry mouth, nausea, decreased appetite, dizziness, sexual side effects, and problems passing urine.
“Today’s approvals mark an important step forward in bringing consumers additional treatments that have met the FDA’s rigorous standards,” stated Kathleen Uhl, MD, 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.”
The FDA recommends that patients taking this medication be monitored appropriately and observed closely for clinical worsening and unusual changes in behavior, especially during the first few months of drug therapy or at times of dose changes. Other important warnings include the risk of severe liver damage and potential for serious cardiovascular events.
- FDA approves first generic Strattera for the treatment of ADHD [press release]. U.S. Food & Drug Administration. May 30, 2017.