NDAORALTABLET
Approved
Oct 1981
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
XANAX (alprazolam) by Viatris (2) is 1,4 benzodiazepine. Approved for panic disorder, generalized anxiety disorder, anxiety disorder. First approved in 1981.
Drug data last refreshed 18h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XANAX (alprazolam) is a 1,4-benzodiazepine approved in 1981 for the acute treatment of generalized anxiety disorder and panic disorder. It works by binding to GABAA receptors and enhancing GABA-mediated synaptic inhibition in the brain. The drug is administered orally as a tablet, with peak plasma concentrations occurring 1-2 hours post-dose and a mean elimination half-life of approximately 11.2 hours in healthy adults. XANAX remains a foundational anxiolytic agent despite its approaching loss of exclusivity status.
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Mechanism of Action
1,4 benzodiazepine. Alprazolam exerts its effect for the acute treatment of generalized anxiety disorder and panic disorder through binding to the benzodiazepine site of gamma-aminobutyric acid-A (GABAA) receptors in the brain and enhances GABA-mediated synaptic inhibition. 12.3 Pharmacokinetics…
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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.