NDAINJECTIONINJECTABLEPriority Review
Approved
Dec 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
3/8 — Basic
Priority Review
ROMAZICON (flumazenil) by Roche is clinical pharmacology: flumazenil, an imidazobenzodiazepine derivative, antagonizes the actions of benzodiazepines on the central nervous system. First approved in 1991.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Romazicon (flumazenil) is a benzodiazepine receptor antagonist administered intravenously to reverse sedation and central nervous system depression caused by benzodiazepines. It competitively inhibits benzodiazepine activity at the GABA receptor complex, with onset of reversal typically evident within 1–2 minutes and peak effect at 6–10 minutes. The drug is indicated for anxiety, hypersomnia, and narcolepsy, though primary use is acute reversal of benzodiazepine overdose in clinical and perioperative settings.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%); brand team likely focused on cost defense and transition planning rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY: Flumazenil, an imidazobenzodiazepine derivative, antagonizes the actions of benzodiazepines on the central nervous system. Flumazenil competitively inhibits the activity at the benzodiazepine recognition site on the GABA/benzodiazepine receptor complex. Flumazenil is a weak…
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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.