Liver Transplant Rejection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-11-18FDA Approved: TACROLIMUS — Supplemental Application (Jubilant Cadista Pharmaceuticals Inc.)
FDA approved Jubilant Cadista Pharmaceuticals Inc.’s supplemental application for tacrolimus, approving a generic tacrolimus product under a…
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FDA approval · 2019-10-18FDA Approved: SIROLIMUS — Original Application (Amneal Pharmaceuticals NY LLC)
The FDA approved Amneal Pharmaceuticals NY LLC for an original application of sirolimus (Rapamune), a generic form of rapamycin, to prevent …
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FDA approval · 2019-10-04FDA Approved: TACROLIMUS — Supplemental Application (Quallent Pharmaceuticals Health LLC)
FDA approved a supplemental application for tacrolimus from Quallent Pharmaceuticals Health LLC, granting an additional regulatory action to…
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CLINICAL_TRIALS withdrawal · 2019-09-23Clinical Trial Update: Budesonide for Immunosuppression After Liver Transplantation to Reduce Side Effects [Phase 4]
A Phase 4 study evaluating budesonide for immunosuppression after liver transplantation was withdrawn.
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FDA approval · 2019-09-17FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)
The FDA approved a supplemental application for tacrolimus from Sandoz Inc., resulting in changes to the approved product, such as labeling …
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FDA approval · 2019-06-11FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)
The FDA approved a supplemental application for Prograf (tacrolimus) filed by Astellas Pharma US, Inc. The action updates the labeling to re…
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FDA approval · 2019-02-27FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil) filed by Genentech, resulting in an approved change to the prod…
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FDA approval · 2019-01-08FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (CONCORD BIOTECH LIMITED)
FDA approved the original application for mycophenolate mofetil (CONCORD BIOTECH LIMITED) for prevention of organ transplant rejection in ki…
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FDA approval · 2018-08-23FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil) submitted by Genentech, Inc.
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CLINICAL_TRIALS trial_result · 2018-07-27Clinical Trial Update: Comparison of Safety and Efficacy of Two Variants of Prolonged - Released Tacrolimus (Advagraf vs. Envarsus ) in Patients After Liver Transplantation : Single Center Randomised Control Trial [NA]
A single-center randomized trial compares two prolonged-release tacrolimus variants (Advagraf vs Envarsus) to evaluate safety and efficacy a…
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FDA approval · 2018-05-24FDA Approved: PROGRAF — Original Application (Astellas Pharma US, Inc.)
FDA approves PROGRAF (tacrolimus) under the original application for prevention of organ transplant rejection in kidney, liver, and heart tr…
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FDA approval · 2018-05-24FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)
The FDA approved a supplemental application for PROGRAF (tacrolimus) submitted by Astellas Pharma US, Inc.
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CLINICAL_TRIALS research · 2018-04-06Clinical Trial Update: MSC Therapy in Liver Transplantation [Phase 1]
Phase 1 clinical trial update investigating mesenchymal stem cell therapy for liver transplant rejection.
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FDA approval · 2017-12-18FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for Cellcept (mycophenolate mofetil) from Genentech, Inc., authorizing changes to the product’s …
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FDA approval · 2017-11-30FDA Approved: TACROLIMUS — Original Application (BPI Labs LLC)
The FDA approved an original application for tacrolimus from BPI Labs LLC, authorizing a generic tacrolimus product to prevent organ transpl…
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FDA approval · 2017-08-23FDA Approved: MYCOPHENOLIC ACID — Original Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare Inc.'s original application for mycophenolic acid, enabling its generic use as an immunosuppressant to preven…
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FDA approval · 2017-01-06FDA Approved: ENVARSUS XR — Supplemental Application (Veloxis Pharmaceuticals, Inc)
FDA processed a supplemental approval for ENVARSUS XR (tacrolimus) from Veloxis Pharmaceuticals, potentially expanding its labeling or indic…
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FDA approval · 2016-10-28FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Endo USA, Inc.)
FDA approves Endo USA, Inc.'s generic mycophenolate mofetil original application (ANDA 203575), enabling its use to prevent organ transplant…
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FDA approval · 2016-08-01FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for Mycophenolate mofetil from Strides Pharma Science Limited under an ANDA.
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FDA approval · 2016-08-01FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for the generic drug Mycophenolate mofetil from Strides Pharma Science Limited, finalizing changes t…
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FDA approval · 2016-06-22FDA Approved: ENVARSUS XR — Supplemental Application (Veloxis Pharmaceuticals, Inc)
The FDA approved a supplemental application for ENVARSUS XR (tacrolimus) submitted by Veloxis Pharmaceuticals, Inc., adding/updating its ind…
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FDA approval · 2016-06-07FDA Approved: ENVARSUS XR — Supplemental Application (Veloxis Pharmaceuticals, Inc)
The FDA approved a supplemental application for ENVARSUS XR (tacrolimus) submitted by Veloxis Pharmaceuticals, Inc. The approval is for the …
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FDA approval · 2016-05-26FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil) submitted by Genentech, Inc. The action authorizes changes unde…
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FDA approval · 2016-01-22FDA Approved: TACROLIMUS — Supplemental Application (Strides Pharma Science Limited)
The FDA approved a supplemental application for tacrolimus from Strides Pharma Science Limited.
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CLINICAL_TRIALS trial_result · 2015-12-14Clinical Trial Update: Cell Infusion Intraportal Autologous Bone Marrow Mononuclear as Enhancer of Liver Regeneration [Phase 2]
This update reports the completion of a Phase 2 clinical trial evaluating intraportal infusion of autologous bone marrow mononuclear cells t…