Kidney Transplant Rejection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-11-10FDA Approved: TACROLIMUS — Original Application (Biocon Pharma Inc.)
FDA approved a Tacrolimus generic from Biocon Pharma Inc. (ANDA212297) for immunosuppression to prevent organ transplant rejection in kidney…
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FDA approval · 2020-08-12FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories' supplemental application for mycophenolate mofetil, granting approval of a generic product for preventing …
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FDA approval · 2020-08-12FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for mycophenolate mofetil submitted by Ascend Laboratories, LLC. This action updates the product's r…
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FDA approval · 2020-07-31FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (CONCORD BIOTECH LIMITED)
FDA approved the Original Application for mycophenolate mofetil from Concord Biotech Limited, providing a generic version of the immunosuppr…
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FDA approval · 2020-06-16FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for mycophenolate mofetil from Hikma Pharmaceuticals USA Inc. for the generic formulation.
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FDA approval · 2019-12-13FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil) submitted by Genentech, Inc.
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FDA approval · 2019-11-27FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for mycophenolate mofetil submitted by Hikma Pharmaceuticals USA Inc. The approval may involve label…
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FDA approval · 2019-11-25FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)
The FDA approved a supplemental application for mycophenolate mofetil from Concord Biotech Limited.
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FDA approval · 2019-11-22FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for a generic version of mycophenolate mofetil by Strides Pharma Science Limited. Indications includ…
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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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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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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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FDA approval · 2018-04-13FDA Approved: NULOJIX — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
FDA approved a supplemental application for NULOJIX (belatacept) filed by E.R. Squibb & Sons, L.L.C. to update the product labeling.
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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 · 2017-05-09FDA Approved: NULOJIX — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
FDA approved a supplemental application for NULOJIX (belatacept) submitted by E.R. Squibb & Sons, L.L.C.
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FDA approval · 2017-02-02FDA Approved: NULOJIX — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
The FDA approved a supplemental application for NULOJIX (belatacept) submitted by E.R. Squibb & Sons, L.L.C.