Generic ADHD Drug Receives Multiple FDA Approvals

Yesterday, the FDA approved the first generic versions of atomoxetine (Strattera) to treat pediatric and adult patients with attention-deficit/hyperactivity disorder (ADHD). Atomoxetine is a is a selective norepinephrine reuptake inhibitor.

The FDA granted approval for generic atomoxetine in multiple doses to Apotex, Teva Pharmaceuticals, Aurobindo Pharma Limited, and Glenmark Pharmaceuticals Limited, according to a press release.

Specifically, Glenmark reported they received approval for atomoxetine capsules, 10-mg, 18-mg, 25-mg, 40-mg, 60-mg, 80-mg, and 100-mg,

To receive approval, generic drugs must show the same quality and strength as the branded drug. Additionally, manufacturing and packaging sites must pass the same quality standards as the branded drug, according to the release. These drugs are known to provide disease control and also limit out-of-pocket costs.

Patients with ADHD have a continual pattern of inattention and/or hyperactivity-impulsivity. These symptoms can interfere with development and day-to-day life. If left untreated in children, they may have difficulties paying attention and completing school work.

In clinical trials including children and adolescents, common side effects included upset stomach, decreased appetite, nausea, vomiting, dizziness, tiredness, and mood swings, according to the release. Among adults, researchers reported side effects such as constipation, dry mouth, nausea, decreased appetite, dizziness, problems passing urine, and sexual side effects.

The FDA advises that atomoxetine should be administered with a Medication Guide, which discloses the drug’s indications and warning.

Atomoxetine has a boxed warning that alerts patients and providers of an increased risk of suicidal ideation in children and adolescents. Young patients taking this drug should be monitored and observed for clinical progression, suicidal thoughts and behaviors, and atypical changes in behavior, according to the release. Patients should be closely monitored, especially during the first few months of treatment or at dose changes.

The FDA also warns that atomoxetine may increase the risk of liver damage and serious cardiovascular events.

"Today’s approvals mark an important step forward in bringing consumers additional treatments that have met the FDA’s rigorous standards," said 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."