The U.S. Food and Drug Administration approved the first generic versions of atomoxetine (Strattera) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. Atomoxetine is approved for treatment of ADHD in adults and children ages six and older with the disorder.
The patent on Ely Lilly’s Strattera expired on May 26, and multiple drug makers were waiting on FDA approval for their version of the drug.
Apotex Inc., Teva Pharmaceuticals USA Inc., Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited were granted approval to market the generic in multiple strengths.
The approvals not only brings consumers additional treatments, but meets a goal of the FDA. “Quickly bringing generics to market so patients have more options to treat their conditions is a top priority for the FDA,” said Kathleen Uhl, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research in a statement.
According to the FDA’s announcement, in clinical trials for atomoxetine in children and adolescents the most common side effects 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 has a boxed warning for the increased risk of suicidal ideation in children and adolescents.
The medication must be dispensed with a patient Medication Guide that describes the drug’s uses and warnings, said the FDA in a statement. “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.”
Approximately four percent of adults and 11 percent of children in the U.S. are diagnosed with ADHD. Symptoms include inattentiveness, hyperactivity, and impulsivity. Patients with the disorder may be prescribed a stimulant or non-stimulant drug as part of their treatment.
Atomoxetine, a selective norepinephrine reuptake inhibitor, is a non-stimulant drug. The precise mechanism of action is unknown, but is thought to be related to its selective inhibition of presynaptic norepinephrine reuptake in the prefrontal cortex.