FDA approves first generic versions of Strattera (atomoxetine)- Drug Information Update

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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.

In the 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 the 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 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. 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.

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