FDA Clears First Generic Versions of Strattera for ADHD

Megan Brooks

May 30, 2017

The US Food and Drug Administration (FDA) has approved the first generic versions of Strattera (atomoxetine, Eli Lilly) to treat children and adults with attention-deficit/hyperactivity disorder (ADHD).

The generic versions of Strattera, which come in multiple strengths, are from Apotex Inc, Teva Pharmaceuticals USA Inc, Aurobindo Pharma Limited, and Glenmark Pharmaceuticals Limited.

"Today's approvals mark an important step forward in bringing consumers additional treatments that have met the FDA's rigorous standards," Kathleen Uhl, MD, director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research, said in a news release. "Quickly bringing generics to market so patients have more options to treat their conditions is a top priority for the FDA."

Atomoxetine is a selective norepinephrine reuptake inhibitor used to treat ADHD in adults and children.

In clinical trials of 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 clinical trials in adults, the most common side effects reported were constipation, dry mouth, nausea, decreased appetite, dizziness, sexual side effects, and problems passing urine.

Atomoxetine has a boxed warning noting an increased risk for suicidal ideation in children and adolescents.

"Patients taking this medication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course 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," the FDA said.

Atomoxetine must be dispensed with a patient medication guide that describes the drug's uses and warnings.

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