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
|Mar 2, 2021||Approval FDA Approves Azstarys (serdexmethylphenidate and dexmethylphenidate) Capsules for the Once-Daily Treatment for ADHD|
|Mar 2, 2020||KemPharm Submits KP415 NDA to the FDA for the Treatment of ADHD|
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