The US Food & Drug Administration (FDA) has approved a generic form of Eli Lilly and Company's Strattera (atomoxetine), used to treat patients with attention-deficit/hyperactivity disorder (ADHD). The generic non-stimulant ADHD medication will be brought to market by Apotex Inc., Teva Pharmaceuticals USA Inc., Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited.
Kathleen Uhl, MD, director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research, highlighted the importance of generic medication, commenting: "Quickly bringing generics to market so patients have more options to treat their conditions is a top priority for the FDA."
Generic medication accounts for around nine out of ten prescriptions filled in the United States and they are usually cheaper than their branded counterparts. The addition of new generics to the market provides patients with an effective way to reduce their healthcare costs. Generics approved by the FDA are required to have the same quality, strength and pass the same quality controls as brand name drugs.
ADHD is a mental health disorder with an extensive variety of potential symptoms. When making a diagnosis, doctors will look for a six or more signs of ADHD in children, and five or more in adults. Among the symptoms specified by the American Psychiatric Association (APA) are inattention, hyperactivity, disorganization and impulsivity.
According to the APA, approximately five percent of children and 2.5 percent of adults have ADHD. Medication, such as Ritalin (methylphenidate), Strattera (atomoxetine) and Focalin (dexmethylphenidate) are often prescribed to treat the condition. However, the American Academy of Pediatrics guidelines state behavior therapy should be the first line treatment in young children.
The medication will be manufactured by Aurobindo Pharma and be made available in capsule form. Seven dosages will be available at pharmacies: 10mg, 18mg, 25mg, 40mg, 60mg, 80mg and 100mg.
Atomoxetine is a non-stimulant treatment for ADHD and works by affecting the chemicals in the brain that play a part in controlling impulses and hyperactivity.
During clinical trials of children and adolescents, the most common side effects were an upset stomach, diminished appetite, nausea or vomiting, dizziness, mood swings and fatigue.
Side effects seen in adults included constipation, dry mouth, lower appetite, dizziness, problems urinating, sexual side effects and nausea.