FDA Approves First Generic Strattera for ADHD Treatment

The United States Food and Drug Administration today approved the first generic versions of Strattera (atomoxetine) to treat attention deficit / hyperactivity disorder (ADHD) in pediatric and adult patients.

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Apotex Inc., Teva Pharmaceuticals USA Inc., Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited today received approval to market atomoxetine at multiple strengths.

“Today’s approvals mark an important step forward to bring consumers additional treatments that meet stringent FDA standards,” said Kathleen Uhl, MD, director of the Office of Generic Drugs at the Center for Drug Evaluation and Research Medications of the FDA. “Bringing generic drugs to the market quickly so patients have more options to treat their conditions is a priority for the FDA.”

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

ADHD is marked by a continuous pattern of inattention and / or hyperactivity-impulsivity that interferes with functioning or development.

In the clinical trials of atomoxetine in children and adolescents, the most common reported side effects were stomach upset, decreased appetite, nausea or vomiting, dizziness, tiredness, and mood swings. In adult clinical trials, the most common reported side effects were constipation, dry mouth, nausea, decreased appetite, dizziness, sexual side effects, and urine problems.

Atomoxetine should be dispensed with a patient medication guide describing the uses and warnings of the drug. This medicine has a boxed warning for the increased risk of suicidal ideation in children and adolescents. Patients taking this medication should be adequately monitored and observed closely for clinical worsening, suicidality, and unusual behavioral changes, especially during the initial months of a course of drug treatment, or at times of dose changes. Other important warnings include the risk of severe liver damage and the potential for serious cardiovascular events.

The FDA, an agency within the US Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and safety of medications, vaccines, and other biological products for human use and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and to regulate tobacco products.