NDAINJECTIONINJECTABLE
Approved
Jun 1960
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
AQUAMEPHYTON (phytonadione) by R-Pharm US is 1 for parenteral injection, possesses the same type and degree of activity as does naturally-occurring vitamin k, which is necessary for the production via the liver of active prothrombin (factor ii), proconvertin (factor vii), plasma thromboplastin component (factor ix), and stuart factor (factor x). Approved for the following coagulation disorders which are due to faulty formation of factors ii, interference with vitamin k activity: • anticoagulant-induced hypoprothrombinemia caused by coumarin, indanedione derivatives and 1 more indications. First approved in 1960.
Drug data last refreshed 15h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AQUAMEPHYTON (phytonadione) is a parenteral vitamin K formulation that restores hepatic synthesis of vitamin K-dependent clotting factors II, VII, IX, and X. It treats coagulation disorders caused by anticoagulant interference (coumarin/indanedione derivatives) and vitamin K deficiency states. The drug works by serving as an essential cofactor for microsomal enzymes that carboxylate glutamic acid residues, converting inactive clotting factor precursors into their active forms.
LOE Approaching
As LOE approaches, the brand team will likely shrink; opportunities lie in supporting generic transition and managing end-of-life brand obligations at R-Pharm US.
Mechanism of Action
1 for parenteral injection, possesses the same type and degree of activity as does naturally-occurring vitamin K, which is necessary for the production via the liver of active prothrombin (factor II), proconvertin (factor VII), plasma thromboplastin component (factor IX), and Stuart factor (factor…
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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.