AUVI-Q
Details
- Status
- Prescription
- First Approved
- 2012-08-10
- Routes
- INTRAMUSCULAR, SUBCUTANEOUS
- Dosage Forms
- SOLUTION
AUVI-Q Approval History
What AUVI-Q Treats
2 indicationsAUVI-Q is approved for 2 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anaphylaxis
- Allergic Reaction
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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.
AUVI-Q FDA Label Details
ProIndications & Usage
FDA Label (PDF)AUVI-Q® is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. AUVI-Q is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a histo...
AUVI-Q Patents & Exclusivity
Patents (72 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.