Kidney Transplantation
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Sign up freeTop drugs studied for this disease
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FDA approval · 2015-05-28FDA Approved: SIROLIMUS — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for sirolimus submitted by Mylan Pharmaceuticals, granting regulatory approval for changes to th…
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FDA approval · 2014-09-30FDA Approved: NULOJIX — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
The FDA approved a supplemental application for NULOJIX (belatacept) from E.R. Squibb & Sons, L.L.C., related to kidney transplantation.
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FDA approval · 2014-07-22FDA Approved: TACROLIMUS — Original Application (Strides Pharma Science Limited)
FDA approved Strides Pharma Science Limited's tacrolimus original application, enabling a generic tacrolimus product for prevention of organ…
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FDA approval · 2013-09-27FDA 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 · 2013-09-27FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for a generic mycophenolate mofetil product from Strides Pharma Science Limited, enabling its market…
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FDA approval · 2013-09-04FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)
The FDA approved a supplemental application for PROGRAF (tacrolimus) submitted by Astellas Pharma US, Inc. The action relates to an update o…
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FDA approval · 2013-08-16FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)
FDA approves a supplemental application for PROGRAF (tacrolimus) filed by Astellas Pharma US, approving changes to the product labeling.
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FDA approval · 2013-07-19FDA Approved: ASTAGRAF XL — Original Application (Astellas Pharma US, Inc.)
FDA approved ASTAGRAF XL (tacrolimus extended-release capsules) under an Original Application from Astellas Pharma US. It provides a new tac…
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FDA approval · 2012-12-10FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)
FDA approved a supplemental application for tacrolimus from Sandoz Inc., updating labeling related to its use in preventing organ transplant…
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FDA approval · 2012-09-25FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approves a supplemental application for mycophenolate mofetil, the generic immunosuppressant, via Teva Pharmaceuticals USA, Inc. This ac…
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FDA approval · 2012-08-31FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)
The FDA approved a supplemental application for mycophenolate mofetil from Strides Pharma Science Limited. This approval supports continued …
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FDA approval · 2012-08-29FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application to allow Strides Pharma Science Limited to market a generic version of mycophenolate mofetil.
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FDA approval · 2012-06-08FDA 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 · 2012-02-06FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)
The FDA approved a supplemental application for PROGRAF (tacrolimus) from Astellas Pharma US, Inc., updating its label to cover transplant-r…
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FDA approval · 2010-09-17FDA Approved: TACROLIMUS — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved the original application for tacrolimus from Mylan Pharmaceuticals, enabling generic access to this immunosuppressant used to p…
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FDA approval · 2010-06-10FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Strides Pharma Science Limited)
FDA approved a generic version of mycophenolate mofetil under an Original Application by Strides Pharma Science Limited. Indications include…
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FDA approval · 2010-04-20FDA Approved: ZORTRESS — Original Application (Novartis Pharmaceuticals Corporation)
FDA approved ZORTRESS (everolimus) under Novartis's Original Application, marking the original approval of the drug for use in preventing or…
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FDA approval · 2009-11-30FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for Accord Healthcare's generic mycophenolate mofetil. The product is used to prevent organ transpla…
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FDA approval · 2009-10-08FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approved Genentech's supplemental application for Cellcept (mycophenolate mofetil hydrochloride).
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FDA approval · 2009-05-04FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved an original application for a generic mycophenolate mofetil manufactured by Mylan Pharmaceuticals Inc, for organ transplant rej…
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FDA approval · 2009-02-13FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)
FDA approved a supplemental application for PROGRAF (tacrolimus) from Astellas Pharma US, Inc., indicating an approved change to the existin…
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FDA approval · 2007-12-20FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for CellCept to update labeling, expanding its use for prevention of organ transplant rejection in r…
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FDA approval · 2007-10-17FDA Approved: SIROLIMUS — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Sirolimus from Mylan Pharmaceuticals Inc., indicating an approved change or addition to the prod…
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FDA approval · 2007-09-21FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for CellCept (mycophenolate mofetil) from Genentech, Inc., likely resulting in an updated indica…
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FDA approval · 2007-05-02FDA Approved: SIROLIMUS — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for sirolimus submitted by Mylan Pharmaceuticals Inc., resulting in changes to the labeling and/…