The Food and Drug Administration has approved the first generic versions of Strattera (atomoxetine) for the treatment of attention-deficit/hyperactivity disorder, the agency announced May 30.
Apotex, Teva Pharmaceuticals USA, Aurobindo Pharma, and Glenmark Pharmaceuticals all gained approval to market generic atomoxetine at various strengths. All versions must be sold with a patient medication guide describing the uses and risks of atomoxetine and must also include a boxed warning detailing the potential for increased risk of suicidal ideation in children and adolescents.
Strattera, a selective norepinephrine reuptake inhibitor, is approved for both pediatric and adult patients. The most common side effects in pediatric patients are upset stomach, decreased appetite, nausea or vomiting, dizziness, tiredness, and mood swings. In adults, the most common side effects are 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. Quickly bringing generics to market so patients have more options to treat their conditions is a top priority for the FDA,” Kathleen Uhl, MD , director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, said in a press release.
Find the full press release on the FDA website .