AMPHETAMINE SULFATE
AMPHETAMINE SULFATE is indicated for the treatment of Narcolepsy; Attention Deficit Hyperactivity Disorder; Exogenous Obesity.
Details
- Status
- Prescription
- First Approved
- 1984-08-31
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
AMPHETAMINE SULFATE Approval History
What AMPHETAMINE SULFATE Treats
3 indicationsAMPHETAMINE SULFATE is approved for 3 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Narcolepsy
- Attention Deficit Hyperactivity Disorder
- Exogenous Obesity
AMPHETAMINE SULFATE Boxed Warning
ABUSE, MISUSE, AND ADDICTION Amphetamine sulfate 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 sulfate, can result in overdose and death ( see OVERDOSAGE ), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing amphetamine sulfate tablets, assess each patient’s risk for...
WARNING: ABUSE, MISUSE, AND ADDICTION Amphetamine sulfate 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 sulfate, can result in overdose and death ( see OVERDOSAGE ), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing amphetamine sulfate 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 sulfate 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 DRUG ABUSE AND DEPENDENCE ).
AMPHETAMINE SULFATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to AMPHETAMINE SULFATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03659929 results posted | AR19.004 | Ph 3 | completed | Adult Attention Deficit Hyperactivity Disorder (ADHD) Study With Amphetamine Sulfate |
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 SULFATE FDA Label Details
Indications & Usage
AMPHETAMINE SULFATE is indicated for the treatment of Narcolepsy; Attention Deficit Hyperactivity Disorder; Exogenous Obesity.
WARNING: ABUSE, MISUSE, AND ADDICTION Amphetamine sulfate 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 sulfate, can result in overdose and death ( see ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.