VIOKACE (pancrelipase (amylase)
VIOKACE is indicated for the treatment of Exocrine Pancreatic Insufficiency; Chronic Pancreatitis.
How VIOKACE Works
VIOKACE contains a mixture of lipases, proteases, and amylases that function as a replacement for physiological enzymes normally secreted by the pancreas. These enzymes catalyze the hydrolysis of fats into fatty acids, proteins into amino acids, and starches into simple sugars. This catalytic activity occurs in the duodenum and proximal small intestine, facilitating the breakdown of macronutrients into absorbable components.
Details
- Status
- Prescription
- First Approved
- 2012-03-01
- Routes
- ORAL
- Dosage Forms
- TABLET
VIOKACE Approval History
What VIOKACE Treats
2 indicationsVIOKACE is approved for 2 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Exocrine Pancreatic Insufficiency
- Chronic Pancreatitis
VIOKACE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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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.
VIOKACE FDA Label Details
Indications & Usage
FDA Label (PDF)VIOKACE is indicated for the treatment of Exocrine Pancreatic Insufficiency; Chronic Pancreatitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.