FDA Greenlights First Generic Version of ADHD Med

The Food and Drug Administration (FDA) has approved the first generic versions of Strattera (atomoxetine; Eli Lilly) capsules for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adults. 

Apotex, Teva, Aurobindo Pharma, and Glenmark are among the first companies to gain approval to market Atomoxetine Capsules in various strengths. Atomoxetine, a selective norepinephrine reuptake inhibitor (SNRI), is currently approved for use in patients aged 6 years and older. Its precise mechanism in ADHD is unknown but is thought to be related to selective inhibition of the pre-synaptic norepinephrine transporter.

Atomoxetine carries a boxed warning regarding an increased risk of suicidal ideation in children and adolescents. Other major warnings include the risk of severe liver damage and potentially serious cardiovascular events. A Medication Guide describing the drug’s indications and warnings is required with every dispensed prescription.

 

Strattera is currently available as 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, and 100mg strength capsules in 30-count bottles. 

For more information visit FDA.gov.