AMPHETAMINE
Amphetamine extended-release orally disintegrating tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies ] . Limitations of Use The use of amphetamine extended-release orally disintegrating tablets are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g.
Details
- Status
- None (Tentative Approval)
- First Approved
- 2023-06-22
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE, TABLET, ORALLY DISINTEGRATING
AMPHETAMINE Approval History
What AMPHETAMINE Treats
1 FDA approvalsOriginally approved for its first indication in 2023 .
- Other (1)
Other
(1 approval)- • Approved indication (Jun 2023)Letter
AMPHETAMINE Boxed Warning
ABUSE, MISUSE, AND ADDICTION Amphetamine extended-release orally disintegrating tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including amphetamine extended-release orally disintegrating tablets, can result in overdose and death [see Overdosage ( 10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Be...
WARNING: ABUSE, MISUSE, AND ADDICTION Amphetamine extended-release orally disintegrating tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including amphetamine extended-release orally disintegrating tablets, can result in overdose and death [see Overdosage ( 10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing amphetamine extended-release orally disintegrating tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout amphetamine extended-release orally disintegrating tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 )] . WARNING: ABUSE, MISUSE AND ADDICTION See full prescribing information for complete boxed warning. Amphetamine extended-release orally disintegrating tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including amphetamine extended-release orally disintegrating tablets, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing amphetamine extended-release orally disintegrating tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03242772 results posted | Pro00085179 1P50HD093074-01 | Ph 2 | terminated | Impact of Combined Medication and Behavioral Treatment for ASD & ADHD |
| NCT02959892 results posted | TAK-041-1002 U1111-1184-1947, 2016-002346-23 | Ph 1 | completed | A Single-Dose Positron Emission Tomography (PET) Study to Determine the Effect of TAK-041 on Amphetamine-Induced Dopamine Release in the Central Nervous System (CNS) |
| NCT02020408 results posted | 090661 R01MH092793 | Ph 4 | completed | Monoamine Contributions to Neurocircuitry in Eating Disorders |
| NCT00733993 results posted | DA09262 P50DA009262, DPMCDA | Ph 1, Ph 2 | completed | Caffeine and Cocaine |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AMPHETAMINE FDA Label Details
Indications & Usage
Amphetamine extended-release orally disintegrating tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies ] . Limitations of Use The use of amphetamine extended-release orally disintegrating tablets are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions , Use in Specific...
WARNING: ABUSE, MISUSE, AND ADDICTION Amphetamine extended-release orally disintegrating tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including amphetamine extended-release ...
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Full clinical data, patents, trials, and competitive landscape for amphetamine.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.