Liver Transplant Rejection

• 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…

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• 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 · 2007-08-01
  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 · 2006-06-27
  FDA Approved: CYCLOSPORINE — Supplemental Application (Apotex Corp.)

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