NDAINJECTIONINJECTABLE2 Generics Approved
Approved
Jul 1980
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
10
Data completeness
4/8 — Partial
ATIVAN (lorazepam) by Hikma is clinical pharmacology studies in healthy volunteers show that in single high doses lorazepam has a tranquilizing action on the central nervous system with no appreciable effect on the respiratory or cardiovascular systems. First approved in 1980.
Drug data last refreshed 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ATIVAN (lorazepam) is a benzodiazepine administered by injection that acts as a central nervous system depressant with tranquilizing properties. It is indicated for anxiety disorders, acute agitation, and perioperative sedation, working through rapid CNS penetration with peak plasma levels achieved within 2 hours. The drug is conjugated hepatically and excreted renally with a half-life of approximately 12 hours.
LOE Approaching
Product approaching loss of exclusivity with established generic competition; commercial team focus shifts to operational efficiency and cost management rather than market expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY Studies in healthy volunteers show that in single high doses lorazepam has a tranquilizing action on the central nervous system with no appreciable effect on the respiratory or cardiovascular systems. Lorazepam is readily absorbed with an absolute bioavailability of 90%. Peak…
Pharmacologic Class:
Benzodiazepine
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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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.