MYFORTIC
Details
- Status
- Prescription
- First Approved
- 2004-02-27
- Routes
- ORAL
- Dosage Forms
- TABLET, DELAYED RELEASE
MYFORTIC Approval History
What MYFORTIC Treats
1 indicationsMYFORTIC is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Organ Rejection
MYFORTIC Boxed Warning
EMBRYO-FETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)] . Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should presc...
WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)] . Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Myfortic. Patients receiving Myfortic should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient [see Warnings and Precautions (5.2)] . Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression [see Warnings and Precautions (5.3)] . Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections [see Warnings and Precautions (5.4, 5.5)] . WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, and SERIOUS INFECTIONS See full prescribing information for complete boxed warning Use during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning. ( 5.1 , 8.1 , 8.3 ) Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Myfortic. ( 5.2 ) Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression. ( 5.3 ) Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections. ( 5.4 , 5.5 )
MYFORTIC Competitors
Pro3 other drugs also target IMPDH. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (IMPDH). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to MYFORTIC
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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.
MYFORTIC FDA Label Details
ProIndications & Usage
FDA Label (PDF)Myfortic is an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. Use in combination with cyclosporine and corticosteroids. Limitations of Use : Myfortic delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. 1.1 Prophylaxis of Organ Rejection in Kidney Transplant Myfortic ® (mycophenolic acid) is indicated for the prophylaxis of organ rejection in adult patient...
WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevent...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.