NDAINJECTIONINJECTABLEPriority Review
Approved
Sep 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 14h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLOLAN (epoprostenol sodium) is an injectable small-molecule prostacyclin analog approved in 1995 for pulmonary hypertension. It works via dual mechanism: direct vasodilation of pulmonary and systemic arterial beds plus inhibition of platelet aggregation. The drug is administered intravenously and represents a foundational therapy in the pulmonary hypertension treatment arsenal.
$0.471MPart D
LOE ApproachingDeclining
FLOLAN faces significant competitive pressure (30/100) with shrinking Medicare utilization; brand team is likely consolidating resources and transitioning focus to retention and clinical support rather than growth initiatives.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
Evaluation of a New Thermostable Formulation of FLOLAN in Japanese Subjects
Started May 2016
10 enrolled
Cardiovascular Disease
Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)
Started Nov 2011
16 enrolled
Hypertension, Pulmonary
Rapid Switch From Flolan to Remodulin in the Outpatient Clinic
Started Mar 2008
7 enrolled
Hypertension, Pulmonary
Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH
Started Feb 2007
8 enrolled
Pulmonary Arterial Hypertension
A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial Hypertension
Started Oct 2002
39 enrolled
Pulmonary Arterial HypertensionPulmonary Hypertension
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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.