NDAINTRAVENOUSSOLUTION
Approved
Feb 2025
Lifecycle
Growth
Competitive Pressure
30/100
Data completeness
4/8 — Partial
DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE (diltiazem hydrochloride) by R-Pharm US is muscle. Approved for atrial flutter, atrial fibrillation, atrial fibrillation. First approved in 2025.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Diltiazem hydrochloride in 0.72% sodium chloride is an intravenous calcium channel antagonist approved for acute management of atrial fibrillation, atrial flutter, and paroxysmal supraventricular tachycardia. It works by slowing AV nodal conduction and prolonging AV nodal refractoriness, converting arrhythmias to normal sinus rhythm and reducing ventricular rate during rapid atrial rhythms. The drug exhibits frequency-dependent effects on the AV node with minimal impact on normal cardiac conduction at baseline heart rates.
Growth
Early-stage product in growth phase with R-Pharm US backing; commercial teams will focus on hospital formulary penetration and acute-care adoption.
Mechanism of Action
muscle. Paroxysmal Supraventricular Tachycardia: Diltiazem slows AV nodal conduction time and prolongs AV nodal refractoriness. Diltiazem exhibits frequency- (use-) dependent effects on AV nodal conduction such that it may selectively reduce the heart rate during tachycardias involving the AV node…
Indications (2)
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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.