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Azstarys FDA Approval History

Last updated by Judith Stewart, BPharm on March 10, 2021.

FDA Approved: Yes (First approved March 2, 2021)
Brand name: Azstarys
Generic name: dexmethylphenidate and serdexmethylphenidate
Dosage form: Capsules
Company: KemPharm, Inc.
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Azstarys (dexmethylphenidate and serdexmethylphenidate) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.

  • Azstarys contains serdexmethylphenidate, a prodrug of dexmethylphenidate, co-formulated with immediate-release dexmethylphenidate.
  • The drug/prodrug combination is thought to provide an early onset of action and long duration of action without the spikes in dexmethylphenidate concentrations that may be associated with adverse events.
  • Azstarys capsules are taken once daily with or without food.
  • Common side effects include decreased appetite, insomnia, nausea, vomiting, dyspepsia, abdominal pain, decreased weight, anxiety, dizziness, irritability, affect lability, tachycardia, and increased blood pressure.

Development timeline for Azstarys

Sep 21, 2022Open Label Safety Study Shows Improved Sleep for Children With ADHD After One Month of Azstarys
Mar  2, 2021Approval FDA Approves Azstarys (serdexmethylphenidate and dexmethylphenidate) Capsules for the Once-Daily Treatment for ADHD
Mar  2, 2020KemPharm Submits KP415 NDA to the FDA for the Treatment of ADHD

Further information

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