Xelstrym FDA Approval History
Last updated by Judith Stewart, BPharm on March 24, 2022.
FDA Approved: Yes (First approved March 22, 2022)
Brand name: Xelstrym
Generic name: dextroamphetamine
Dosage form: Transdermal System
Company: Noven Pharmaceuticals, Inc.
Treatment for: ADHD
Xelstrym (dextroamphetamine) transdermal system is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and children 6 years and older.
- Amphetamines, including dextroamphetamine, are classified as schedule II controlled substances. Dextroamphetamine is available in oral dosage forms for the treatment of ADHD and narcolepsy under the brand names Dexedrine (sustained-release capsules) and Zenzedi (immediate-release tablets). Xelstrym is the first-and-only FDA-approved transdermal amphetamine patch.
- The Xelstrym patch is applied to the skin once daily. Each patch is worn for 9 hours and then removed. A new patch must be applied every day.
- Xelstrym is associated with the following warnings and precautions: serious cardiovascular reactions, increased blood pressure and heart rate, psychiatric adverse reactions, suppression of growth, peripheral vasculopathy, including Raynaud’s phenomenon, serotonin syndrome, contact sensitization, and application site reactions.
- Common adverse reactions include decreased appetite, headache, insomnia, tics, abdominal pain, vomiting, nausea, irritability, increased blood pressure, and increased heart rate.
Development timeline for Xelstrym
Further information
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