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 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DEXEDRINE SPANSULE is an extended-release oral capsule formulation of dextroamphetamine sulfate, a CNS stimulant that elevates blood pressure and has weak bronchodilator effects. It is used to treat attention-deficit/hyperactivity disorder (ADHD) and narcolepsy by providing gradual, sustained drug release over approximately 12 hours. The mechanism involves sympathomimetic CNS stimulation, though the exact behavioral pathway in ADHD remains incompletely understood.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential team restructuring and reduced investment in brand maintenance.
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.