FDA approves generic Strattera for ADHD in children, adults

The FDA today approved the first generic of Strattera for treatment of ADHD in children and adults.

In addition, Apotex Inc., Teva Pharmaceuticals USA Inc., Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited received approval to market atomoxetine for ADHD in adults and children.

“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 at the FDA’s Center for Drug Evaluation and Research, said in a press release. “Quickly bringing generics to market so patients have more options to treat their conditions is a top priority for the FDA.”

Clinical trials indicated the most common side effects of atomoxetine in children and adolescents were upset stomach, decreased appetite, nausea or vomiting, dizziness, tiredness, and mood swings, according to the release.

Among adults, the most common reported side effects were constipation, dry mouth, nausea, decreased appetite, dizziness, sexual side effects, and issues passing urine.

Atomoxetine must be dispensed with a patient Medication Guide that explains uses and warnings associated with the drug, the release stated.

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

Clinicians should monitor patients receiving atomoxetine for clinical worsening, suicidality and unusual behavioral changes, particularly during the initial few months of drug therapy or at dose changes.

Atomoxetine is also associated with a risk for severe liver damage and potential for serious cardiovascular events, according to the FDA.