NDAORALCAPSULE, EXTENDED RELEASE
Approved
Aug 1976
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
DEXEDRINE SPANSULE (dextroamphetamine sulfate) by R-Pharm US is clinical pharmacology amphetamines are noncatecholamine, sympathomimetic amines with cns stimulant activity. First approved in 1976.
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DEXEDRINE SPANSULE is an extended-release oral capsule containing dextroamphetamine sulfate, a CNS stimulant that elevates sympathomimetic activity. It is indicated for attention deficit disorders and narcolepsy, working through noncatecholamine mechanisms that enhance mental and behavioral focus. The sustained-release formulation delivers drug gradually over ~8 hours, achieving lower peak concentrations than immediate-release tablets while maintaining similar overall bioavailability.
LOE Approaching
With LOE approaching and zero linked job openings, this product is in managed decline; career roles will focus on legacy support and transition planning rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Amphetamines are noncatecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action. There is neither specific evidence that clearly…
Indications
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.