BLAINTRAVENOUSPOWDER, FOR SOLUTION
Approved
Nov 2023
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
Balfaxar (prothrombin complex concentrate (human)) by Octapharma is 12. First approved in 2023.
Drug data last refreshed 5h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Balfaxar is a prothrombin complex concentrate (human) administered intravenously to rapidly restore vitamin K-dependent coagulation factors (II, VII, IX, X) and antithrombic proteins C and S in patients with deficiency. It works by temporarily correcting coagulation defects, reducing INR from a median of 3.0 to 1.30 within 30 minutes post-infusion. The product is indicated for urgent reversal of anticoagulation in surgical and bleeding scenarios.
Growth
Recently approved product in growth phase with moderate competitive pressure (score 30/100), indicating opportunity for commercial team expansion and market establishment.
Mechanism of Action
12.1 Mechanism of Action The administration of BALFAXAR provides a rapid increase in plasma levels of the vitamin K-dependent coagulation factors (FII, FVII, FIX, FX) and antithrombotic proteins C and S. Together they are referred to/known as the prothrombin complex. [ ; ] BALFAXAR can temporarily…
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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.