Liver Transplant Rejection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2013-09-27FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for Mycophenolate mofetil from Strides Pharma Science Limited under the ANDA program. This action au…
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FDA approval · 2013-07-24FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
The FDA approved Genentech's supplemental application for CELLCEPT (mycophenolate mofetil), indicating an approved modification related to i…
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FDA approval · 2013-05-07FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)
FDA approved Sandoz's supplemental application for tacrolimus, making a generic tacrolimus product available for preventing organ transplant…
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FDA approval · 2013-02-14FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil) from Genentech, Inc.
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FDA approval · 2013-02-14FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for CellCept (mycophenolate mofetil) submitted by Genentech, Inc., updating the labeling to refl…
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FDA approval · 2013-02-07FDA Approved: SANDIMMUNE — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for SANDIMMUNE (cyclosporine) from Novartis, indicating updated labeling or expanded use via a suppl…
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FDA approval · 2012-10-12FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)
The FDA approved a supplemental application for tacrolimus submitted by Sandoz Inc.
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FDA approval · 2012-09-25FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for mycophenolate mofetil from Sandoz Inc, authorizing changes to the product as part of the sup…
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FDA approval · 2012-09-25FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for mycophenolate mofetil submitted by Mylan Pharmaceuticals Inc. The action updates the product's l…
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FDA approval · 2012-09-25FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)
The FDA approved a supplemental application for Mycophenolate mofetil from Strides Pharma Science Limited, enabling the generic product to b…
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FDA approval · 2012-09-10FDA Approved: TACROLIMUS — Supplemental Application (Accord Healthcare Inc.)
FDA approves a supplemental application for tacrolimus from Accord Healthcare Inc., resulting in updated labeling and/or indications for the…
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FDA approval · 2012-07-25FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for mycophenolate mofetil from Hikma Pharmaceuticals USA Inc., resulting in changes to the approved …
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FDA approval · 2012-07-25FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for mycophenolate mofetil from Hikma Pharmaceuticals USA Inc., indicating a modification to an a…
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FDA approval · 2012-06-28FDA Approved: TACROLIMUS — Supplemental Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare Inc.'s supplemental application for tacrolimus (generic) to update the product, which is used to prevent orga…
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FDA approval · 2012-06-27FDA Approved: TACROLIMUS — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for tacrolimus submitted by Quallent Pharmaceuticals Health LLC.
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FDA approval · 2011-11-28FDA Approved: TACROLIMUS — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for tacrolimus from Quallent Pharmaceuticals Health LLC to support continued marketing of the im…
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FDA approval · 2011-11-18FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)
FDA approved a supplemental application for tacrolimus submitted by Sandoz Inc. (ANDA065461), authorizing a tacrolimus product as part of th…
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FDA approval · 2011-11-04FDA Approved: TACROLIMUS — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)
FDA approved a supplemental application for tacrolimus submitted by Padagis Israel Pharmaceuticals Ltd.
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FDA approval · 2011-11-04FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Ascend Laboratories, LLC)
The FDA approved Ascend Laboratories' original ANDA for a generic version of mycophenolate mofetil, confirming bioequivalence to the referen…
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FDA approval · 2011-09-27FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)
FDA approved a supplemental application for tacrolimus from Sandoz Inc. This action concerns the generic tacrolimus product.
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FDA approval · 2011-07-14FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)
The FDA approved a supplemental application for PROGRAF (tacrolimus) from Astellas Pharma US, Inc., potentially updating or expanding labeli…
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FDA approval · 2010-02-02FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for Mycophenolate mofetil submitted by Teva Pharmaceuticals USA, Inc.
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FDA approval · 2009-10-08FDA Approved: NEORAL — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for NEORAL (cyclosporine) from Novartis Pharmaceuticals Corporation.
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CLINICAL_TRIALS trial_result · 2009-09-15Clinical Trial Update: A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Liver Transplant Recipients. [Phase 3]
A Phase 3 randomized trial comparing Prograf and Prograf-XL in de novo liver transplant recipients has completed.
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FDA approval · 2009-07-22FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil) submitted by Genentech, Inc.