DEXEDRINE SPANSULE (dextroamphetamine sulfate) · IMPAX LABS
DEXEDRINE is indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of the hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.
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.
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.
Drugs Similar to DEXEDRINE SPANSULE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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 is indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of the hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be pres...
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...
Track DEXEDRINE SPANSULE with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.