SUBLIMAZE PRESERVATIVE FREE

LOE Approaching

fentanyl citrate

NDAINJECTIONINJECTABLEPriority Review
Approved
Feb 1968
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3

Clinical Trials (3)

NCT00343733Phase 3Completed

Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain

Started Aug 2006
120 enrolled
Pain
NCT00214955Phase 3Completed

Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain

Started Sep 2005
120 enrolled
Chronic Neuropathic Pain
NCT00214942Phase 3Completed

Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for Management of Breakthrough Pain

Started Sep 2005
Chronic Low Back Pain
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers
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.