NDAINJECTIONINJECTABLE
Approved
Dec 1990
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
4/8 — Partial
DIAZEPAM (diazepam) by Medica Corp is clinical pharmacology in animals, diazepam appears to act on parts of the limbic system, the thalamus and hypothalamus, and induces calming effects. First approved in 1990.
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Diazepam is a benzodiazepine administered via intramuscular injection that acts on the limbic system, thalamus, and hypothalamus to produce calming and anxiolytic effects. It is indicated for acute anxiety, muscle spasm, seizure management, and alcohol withdrawal, with a mechanism distinct from antipsychotics in that it lacks peripheral autonomic blocking or extrapyramidal effects. The autoinjector formulation provides equivalent bioavailability to manual syringe administration with mean Cmax of 314 ng/mL and Tmax of 1.47 hours.
LOE Approaching
As a legacy benzodiazepine approaching loss of exclusivity with 30% competitive pressure, commercial teams face declining market share and smaller resource allocation.
Mechanism of Action
CLINICAL PHARMACOLOGY In animals, diazepam appears to act on parts of the limbic system, the thalamus and hypothalamus, and induces calming effects. Diazepam, unlike chlorpromazine and reserpine, has no demonstrable peripheral autonomic blocking action, nor does it produce extrapyramidal side…
Pharmacologic Class:
Benzodiazepine
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.