NDAINJECTIONINJECTABLE
Approved
Dec 1990
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
5/8 — 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. Approved for epilepsy, alcohol withdrawal syndrome, seizures. First approved in 1990.
Drug data last refreshed Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Diazepam is a benzodiazepine administered via intramuscular injection for acute management of epilepsy, seizures, and alcohol withdrawal syndrome. It acts on the limbic system, thalamus, and hypothalamus to produce calming effects without extrapyramidal side effects. The drug achieves rapid CNS penetration with a Tmax of approximately 1.5 hours and has a long-acting metabolite (desmethyldiazepam) with a Tmax of ~61 hours.
LOE Approaching
Product approaching loss of exclusivity with legacy-stage commercial expectations; smaller team focus on defending market share against newer anticonvulsants.
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 (3)
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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.