PANCREAZE
PANCREAZE is a pancreatic enzyme product indicated for the treatment of exocrine pancreatic insufficiency. The medication is approved for use in both adult and pediatric patient populations. It serves as a therapeutic replacement for digestive enzymes that are normally secreted by the pancreas to facilitate the breakdown of nutrients.
How PANCREAZE Works
PANCREAZE contains a mixture of lipases, proteases, and amylases that catalyze the hydrolysis of fats, proteins, and starches in the duodenum and proximal small intestine. These enzymes break down fats into monoglycerides and glycerol, proteins into peptides and amino acids, and starches into dextrins and short-chain sugars. By performing these actions, the medication mimics the physiological activity of digestive enzymes naturally secreted by the pancreas.
Details
- Status
- Prescription
- First Approved
- 2010-04-12
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED RELEASE
PANCREAZE Approval History
What PANCREAZE Treats
1 indicationsPANCREAZE is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Exocrine Pancreatic Insufficiency
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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.
PANCREAZE FDA Label Details
ProIndications & Usage
FDA Label (PDF)PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. PANCREAZE ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.