AMPHADASE
Amphadase is an endoglycosidase enzyme used as an adjuvant to facilitate the administration and absorption of fluids and medications. It is indicated for use in subcutaneous fluid administration for hydration and to increase the dispersion of other injected drugs. Additionally, the agent is utilized in subcutaneous urography to improve the resorption of radiopaque agents.
How AMPHADASE Works
Hyaluronidase functions as a dispersion agent by hydrolyzing hyaluronic acid, a polysaccharide found in the intercellular ground substance of connective tissue. By splitting specific glucosaminidic bonds, the enzyme temporarily decreases the viscosity of the cellular cement and increases tissue permeability. This process promotes the dispersion of injected fluids or localized transudates, thereby facilitating their absorption into the body.
Details
- Status
- Prescription
- First Approved
- 2004-10-26
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
AMPHADASE Approval History
What AMPHADASE Treats
1 indicationsAMPHADASE is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dehydration
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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.
AMPHADASE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Amphadase ® is an endoglycosidase indicated as an adjuvant: • in subcutaneous fluid administration for achieving hydration • to increase absorption and dispersion of other injected drugs • in subcutaneous urography for improving resorption of radiopaque agents 1.1 Subcutaneous Fluid Administration Amphadase ® is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. 1.2 Dispersion and Absorption of Injected Drugs Amphadase ® is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs. 1.3 Subcutaneous Urography Amphadase ® is in...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.