PROGRAF
Details
- Status
- Prescription
- First Approved
- 1994-04-08
- Routes
- ORAL, INJECTION
- Dosage Forms
- FOR SUSPENSION, CAPSULE, INJECTABLE
PROGRAF Approval History
What PROGRAF Treats
1 indicationsPROGRAF is approved for 1 conditions since its original approval in 1994. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Organ Rejection
PROGRAF Boxed Warning
MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing serious infections and malignancies with PROGRAF or other immunosuppressants that may lead to hospitalization or death. ( 5.1 , 5.2 ) WARNING: MALIGNANCIES AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Increased risk for developing serious infections and malignancies with PROGRAF or other immunosuppressants that may lead to hospitalization or death. ( 5.1 , 5.2 )...
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing serious infections and malignancies with PROGRAF or other immunosuppressants that may lead to hospitalization or death. ( 5.1 , 5.2 ) WARNING: MALIGNANCIES AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Increased risk for developing serious infections and malignancies with PROGRAF or other immunosuppressants that may lead to hospitalization or death. ( 5.1 , 5.2 )
PROGRAF Target & Pathway
ProTarget
A cytokine that promotes Th2 immune responses and IgE production. IL-4 drives allergic inflammation in atopic dermatitis and asthma. Blocking IL-4 (often together with IL-13) reduces the type 2 inflammation underlying these conditions.
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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.
PROGRAF FDA Label Details
ProIndications & Usage
FDA Label (PDF)PROGRAF is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants. 1.1 Prophylaxis of Organ Rejection in Kidney, Liver, Heart, or Lung Transplant PROGRAF ® is indicated for the prophylaxis of organ rejection, in adult and pediatric patients receiving allogeneic kidney transplant [see Clinical Studies ], liver transplant [see Clinical Studies ], heart transplant [see Clinical Studies ], or lung transplant [see Clinical S...
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing serious infections and malignancies with PROGRAF or other immunosuppressants that may lead to hospitalization or death. ( 5.1 , 5.2 ) WARNING: MALIGNANCIES AND SERIOUS INFECTIONS See full prescribing information for complete ...
PROGRAF Patents & Exclusivity
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.