DEXEDRINE SPANSULE (dextroamphetamine sulfate)
DEXEDRINE SPANSULE is indicated for the treatment of Narcolepsy; Attention Deficit Hyperactivity Disorder.
Details
- Status
- Prescription
- First Approved
- 1976-08-02
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
DEXEDRINE SPANSULE Approval History
What DEXEDRINE SPANSULE Treats
2 indicationsDEXEDRINE SPANSULE is approved for 2 conditions since its original approval in 1976. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Narcolepsy
- Attention Deficit Hyperactivity Disorder
DEXEDRINE SPANSULE Boxed Warning
ABUSE, MISUSE, AND ADDICTION DEXEDRINE has 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 DEXEDRINE, 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 DEXEDRINE, assess each patient’s risk for abuse, misuse, and addiction. Educate patients...
WARNING: ABUSE, MISUSE, AND ADDICTION DEXEDRINE has 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 DEXEDRINE, 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 DEXEDRINE, 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 DEXEDRINE 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 ] .
DEXEDRINE SPANSULE 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.
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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.
DEXEDRINE SPANSULE FDA Label Details
Indications & Usage
FDA Label (PDF)DEXEDRINE SPANSULE is indicated for the treatment of Narcolepsy; Attention Deficit Hyperactivity Disorder.
WARNING: ABUSE, MISUSE, AND ADDICTION DEXEDRINE has 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 DEXEDRINE, can result in overdose and death [see Overdosage ] , and this risk i...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.