Kidney Transplantation
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-07-28FDA 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., related to its use in kidney trans…
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FDA approval · 2021-05-17FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare's supplemental application for mycophenolate mofetil (ANDA 090253), allowing continued marketing of the gener…
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FDA approval · 2021-04-21FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for mycophenolate mofetil from Accord Healthcare Inc., authorizing the generic product's continued m…
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FDA approval · 2021-01-15FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approves a supplemental application for mycophenolate mofetil from Hikma Pharmaceuticals USA Inc., reflecting a labeling update for this…
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FDA approval · 2021-01-15FDA Approved: MYCOPHENOLIC ACID — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for Accord Healthcare Inc.'s mycophenolic acid, supporting its continued regulatory status as a gene…
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FDA approval · 2020-10-16FDA Approved: SIROLIMUS — Original Application (NORTHSTAR RX LLC)
FDA approved a generic sirolimus from NorthStar RX LLC under an Original Application (ANDA 208691) for use in preventing organ transplant re…
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FDA approval · 2020-08-04FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's supplemental application for mycophenolate mofetil, a generic immunosuppressant used to prevent organ transplant rejecti…
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FDA approval · 2020-08-04FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for Mycophenolate mofetil filed by Strides Pharma Science Limited.
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FDA approval · 2020-06-08FDA Approved: EVEROLIMUS — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s generic Everolimus under an Original Application, enabling the sale of a generic version of th…
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FDA approval · 2019-10-22FDA Approved: TACROLIMUS — Supplemental Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare Inc.'s supplemental application for tacrolimus (generic) under ANDA 091195, enabling continued approval of a …
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FDA approval · 2019-09-11FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for Accord Healthcare Inc.'s mycophenolate mofetil. This action updates the regulatory status for th…
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FDA approval · 2019-02-12FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (VistaPharm, LLC)
FDA approves VistaPharm, LLC's generic mycophenolate mofetil for prophylaxis of organ transplant rejection. This Original Application (ANDA …
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FDA approval · 2019-01-31FDA Approved: TACROLIMUS — Original Application (Accord Healthcare Inc.)
The FDA approves Accord Healthcare Inc.'s Original Application for tacrolimus (generic tacrolimus) for prevention of organ transplant reject…
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FDA approval · 2018-11-29FDA Approved: ASTAGRAF XL — Supplemental Application (Astellas Pharma US, Inc.)
The FDA approved a supplemental application for ASTAGRAF XL (tacrolimus extended-release capsules) from Astellas Pharma US, Inc., expanding/…
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FDA approval · 2018-05-24FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)
FDA approved a supplemental application for Prograf (tacrolimus) from Astellas Pharma US, Inc. to update its labeling and indications.
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FDA approval · 2017-12-18FDA 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 · 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 · 2017-03-31FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Mylan Institutional LLC)
The FDA approved the original application for mycophenolate mofetil from Mylan Institutional LLC. It is indicated to prevent organ transplan…
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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.
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FDA approval · 2015-12-15FDA Approved: TACROLIMUS — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for tacrolimus submitted by Mylan Pharmaceuticals Inc.
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FDA approval · 2015-11-13FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for mycophenolate mofetil submitted by Teva Pharmaceuticals USA, Inc., updating the drug's label…
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FDA approval · 2015-11-13FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for a generic version of mycophenolate mofetil from Hikma Pharmaceuticals USA Inc. The drug is u…
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FDA approval · 2015-09-28FDA Approved: TACROLIMUS — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for tacrolimus by Accord Healthcare Inc., expanding the availability of a generic tacrolimus product…
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FDA approval · 2015-08-04FDA Approved: MYFORTIC — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for MYFORTIC (mycophenolic acid) from Novartis Pharmaceuticals Corporation.
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FDA approval · 2015-07-10FDA Approved: ENVARSUS XR — Original Application (Veloxis Pharmaceuticals, Inc)
ENVARSUS XR (tacrolimus) received FDA approval as an original application to prevent organ rejection in kidney transplant recipients.