Drugs
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Atomoxetine (marketed as Strattera) Information
Atomoxine (marketed as Strattera) is currently approved in the United States to treat attention-deficit/hyperactivity disorder (ADHD) in children, adolescents, and adults.
This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this page when additional information or analyses become available
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page.
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Related Information
Information about Medications Used to Treat Attention-Deficit/Hyperactivity Disorder (ADHD) FDA Drug Safety Communication: Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in adults
12/12/2011FDA Drug Safety Communication: Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and young adults
11/1/2011Communication about an Ongoing Safety Review of Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)
6/23/2009; updated 4/2011FDA Asks Attention-Deficit Hyperactivity Disorder (ADHD) Drug Manufacturers to Develop Patient Medication Guides
Issued 2/21/2007Information for Healthcare Professionals: Atomoxetine (marketed as Strattera)
9/29/2005Public Health Advisory: Suicidal Thinking in Children and Adolescents Being Treated With Strattera (Atomoxetine)
9/29/2005FDA Issues Public Health Advisory on Strattera (Atomoxetine) for Attention Deficit Disorder
9/29/2005
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Labeling and Regulatory History from Drugs@FDA
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