FDA Okays Generic Strattera

Officials with the FDA have approved Apotex Inc's, Teva Pharmaceuticals, Aurobindo Pharma Limited, and Glenmark Pharmaceuticals' generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.

In the clinical trials for atomoxetine in children and adolescents, the most common adverse events 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.

A statement from the FDA noted that 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.

"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 prepared statement. "Quickly bringing generics to market so patients have more options to treat their conditions is a top priority for the FDA."

Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic prescription drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

Reference

FDA approves first generic Strattera for the treatment of ADHD [news release]. FDA website. Accessed at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm561096.htm