SENSORCAINE
Details
- Status
- Prescription
- First Approved
- 1981-12-30
- Routes
- INJECTION, SPINAL
- Dosage Forms
- INJECTABLE
Companies
SENSORCAINE Approval History
What SENSORCAINE Treats
2 indicationsSENSORCAINE is approved for 2 conditions since its original approval in 1981. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anesthesia
- Analgesia
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SENSORCAINE FDA Label Details
ProIndications & Usage
FDA Label (PDF)INDICATIONS & USAGE Sensorcaine (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (see WARNINGS). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block) (see ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.