Kidney Transplant Rejection

• FDA approval · 2011-11-04
  FDA 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…

• FDA approval · 2011-09-27
  FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for tacrolimus from Sandoz Inc. This action concerns the generic tacrolimus product.

• FDA approval · 2011-07-14
  FDA 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…

• FDA approval · 2011-06-15
  FDA Approved: NULOJIX — Original Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved NULOJIX (belatacept) via its original biologics license application for the prevention of kidney transplant rejection in adult …

• FDA approval · 2010-02-02
  FDA 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 · 2009-10-08
  FDA Approved: NEORAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for NEORAL (cyclosporine) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2009-07-22
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil) submitted by Genentech, Inc.

• FDA approval · 2009-06-18
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  The FDA approved Genentech's supplemental application for CellCept (mycophenolate mofetil). The action updates the approved status under a s…

• FDA approval · 2009-05-19
  FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for PROGRAF (tacrolimus) filed by Astellas Pharma US, Inc.

• FDA approval · 2009-05-06
  FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's mycophenolate mofetil as an original application; it is used to prevent organ transplant rejection in kidney, liver, and…

• FDA approval · 2009-05-04
  FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's original ANDA for mycophenolate mofetil, authorizing its use to prevent organ transplant rejection in kidne…

• FDA approval · 2009-02-27
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil) submitted by Genentech, Inc. to modify/expand the approved …

• FDA approval · 2008-12-15
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  FDA approved Genentech's supplemental application for Cellcept (mycophenolate mofetil), updating the labeling for prevention of organ reject…

• FDA approval · 2008-12-15
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for CellCept (mycophenolate mofetil) submitted by Genentech, Inc.

• FDA approval · 2008-12-15
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  The FDA approved Genentech's supplemental application for CellCept (mycophenolate mofetil hydrochloride).

• FDA approval · 2008-10-15
  FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Sandoz Inc)

  FDA approved the original application for generic mycophenolate mofetil (Sandoz) for prevention of organ transplant rejection in kidney, hea…

• FDA approval · 2008-05-09
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil hydrochloride) submitted by Genentech, updating the labeling…

• FDA approval · 2008-05-09
  FDA Approved: MYFORTIC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for MYFORTIC (mycophenolic acid) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2008-05-09
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Cellcept (mycophenolate mofetil) from Genentech, Inc., indicating an approved modification t…

• FDA approval · 2008-05-09
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for CellCept (mycophenolate mofetil) from Genentech, resulting in changes to the product labeling.

• FDA approval · 2007-11-02
  FDA Approved: MYFORTIC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for MYFORTIC (mycophenolic acid) from Novartis Pharmaceuticals Corporation, updating labeling to sup…

• FDA approval · 2007-08-01
  FDA Approved: NEORAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for NEORAL (cyclosporine) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2007-07-13
  FDA Approved: GENGRAF — Supplemental Application (AbbVie Inc.)

  FDA approved AbbVie's supplemental application for GENGRAF (cyclosporine), updating the product's approval status under the ANDA process.

• FDA approval · 2007-01-12
  FDA Approved: SIROLIMUS — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for sirolimus from Mylan Pharmaceuticals Inc., authorizing a generic version of the immunosuppressan…

• FDA approval · 2006-06-27
  FDA Approved: CYCLOSPORINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Apotex Corp. to market a generic cyclosporine product.