EXENATIDE SYNTHETIC · AMNEAL
EXENATIDE SYNTHETIC is FDA-approved to treat 1 condition (same as BYETTA).
Details
- Status
- Discontinued
- First Approved
- 2005-04-28
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
EXENATIDE SYNTHETIC Approval History
What EXENATIDE SYNTHETIC Treats
1 indicationsEXENATIDE SYNTHETIC is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 diabetes mellitus
Same approved indications as BYETTA (same active ingredient).
AMNEAL's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
EXENATIDE SYNTHETIC FDA Label Details
Indications & Usage
EXENATIDE SYNTHETIC is FDA-approved to treat 1 condition — same approved indications as BYETTA.
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Full clinical data, patents, trials, and competitive landscape for exenatide synthetic.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.