NDAINTRAVENOUSINJECTABLE
Approved
Dec 2014
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
3/8 — Basic
ARGATROBAN IN 0.9% SODIUM CHLORIDE (argatroban) by Teva is site. First approved in 2014.
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Argatroban in 0.9% sodium chloride is a direct thrombin inhibitor administered intravenously for anticoagulation. It works by binding directly to thrombin's active site without requiring antithrombin III as a cofactor, inhibiting thrombin-catalyzed reactions including fibrin formation and platelet aggregation. This mechanism enables rapid anticoagulation in patients with heparin-induced thrombocytopenia (HIT) and related thrombotic conditions.
Peak
Product is in peak commercial lifecycle with moderate competitive pressure (30 score); teams managing established market presence in specialty anticoagulation segment.
Mechanism of Action
site. Argatroban does not require the co-factor antithrombin III for antithrombotic activity. Argatroban exerts its anticoagulant effects by inhibiting thrombin-catalyzed or -induced reactions, including fibrin formation; activation of coagulation factors V, VIII, and XIII; activation of protein C;…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion
Started Nov 2010
9 enrolled
Coronary Artery Bypass Graft SurgeryPresence of Heparin/Platelet Factor 4 Antibody
Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin
Started Sep 2003
24 enrolled
ThrombocytopeniaThrombosis
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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.