Heart Transplantation

• FDA approval · 2012-02-06
  FDA 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…

• FDA approval · 2010-09-17
  FDA 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…

• FDA approval · 2010-06-10
  FDA 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…

• FDA approval · 2009-11-30
  FDA 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…

• FDA approval · 2009-10-08
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

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

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2009-05-04
  FDA 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…

• FDA approval · 2009-02-13
  FDA 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…

• FDA approval · 2007-12-20
  FDA 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…

• FDA approval · 2007-10-17
  FDA 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…

• FDA approval · 2007-09-21
  FDA 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…

• FDA approval · 2007-05-02
  FDA 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/…