VALIUM
LOE ApproachingNDAINJECTIONINJECTABLE
Approved
Aug 1966
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
VALIUM by Roche is clinical pharmacology diazepam is a benzodiazepine that exerts anxiolytic, sedative, muscle-relaxant, anticonvulsant and amnestic effects. Approved for anxiety disorders, for the short- term relief of the symptoms of anxiety. First approved in 1966.
Drug data last refreshed 5h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VALIUM (diazepam) is a classic benzodiazepine administered via injection for rapid anxiolysis, muscle relaxation, and seizure management. It crosses the blood-brain barrier quickly to modulate GABA neurotransmission, producing sedative and anticonvulsant effects. The injectable formulation is used in acute care and perioperative settings where rapid onset is critical.
LOE Approaching
A legacy injectable benzodiazepine with moderate competitive pressure (30%) approaching loss of exclusivity; brand team likely focused on cost management and institutional relationships rather than growth.
Mechanism of Action
CLINICAL PHARMACOLOGY Diazepam is a benzodiazepine that exerts anxiolytic, sedative, muscle-relaxant, anticonvulsant and amnestic effects. Most of these effects are thought to result from a facilitation of the action of gamma aminobutyric acid (GABA), an inhibitory neurotransmitter in the central…
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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.