Data updated: Mar 10, 2026
GALLIUM GA 68 EDOTREOTIDE
GALLIUM GA-68 EDOTREOTIDE
Approved 2019-08-21
2
Indications
--
Phase 3 Trials
6
Years on Market
Details
- Status
- Prescription
- First Approved
- 2019-08-21
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
GALLIUM GA 68 EDOTREOTIDE Approval History
Loading approval history...
What GALLIUM GA 68 EDOTREOTIDE Treats
2 FDA approvalsOriginally approved for its first indication in 2019 . Covers 2 distinct patient populations.
- Other (2)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
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.
GALLIUM GA 68 EDOTREOTIDE FDA Label Details
ProGALLIUM GA 68 EDOTREOTIDE Patents & Exclusivity
Exclusivity: Aug 2026
Exclusivity
ODE-383
Until Aug 2026
W
Until Aug 2026
Source: FDA Orange Book
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.