NDAORALCAPSULEPriority Review
Approved
Feb 1960
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
Priority Review
LIBRIUM (chlordiazepoxide hydrochloride) by Bausch + Lomb is clinical pharmacology chlordiazepoxide hcl has antianxiety, sedative, appetite-stimulating and weak analgesic actions. Approved for anxiety disorders, for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism and 3 more indications. First approved in 1960.
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Librium (chlordiazepoxide HCl) is a benzodiazepine oral capsule approved in 1960 that acts on the limbic system to reduce anxiety, fear, and aggression. It is indicated for anxiety disorders, acute alcohol withdrawal, and preoperative apprehension, with a mechanism involving blockade of EEG arousal from the brain stem reticular formation. The drug has a long half-life of 24-48 hours and slow plasma clearance over several days.
LOE Approaching
Product is approaching loss of exclusivity with minimal commercial data available; teams are likely focused on managed care and generic transition planning rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Chlordiazepoxide HCl has antianxiety, sedative, appetite-stimulating and weak analgesic actions. The precise mechanism of action is not known. The drug blocks EEG arousal from stimulation of the brain stem reticular formation. It takes several hours for peak blood levels to be…
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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.