Heart Transplantation

• FDA approval · 2019-10-22
  FDA 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 …

• FDA approval · 2019-09-11
  FDA 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…

• FDA approval · 2019-02-12
  FDA 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 …

• FDA approval · 2019-01-31
  FDA 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…

• FDA approval · 2018-11-29
  FDA 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 · 2018-05-24
  FDA 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.

• FDA approval · 2017-12-18
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for CELLCEPT (MYCOPHENOLATE MOFETIL) submitted by Genentech, Inc.

• FDA approval · 2017-03-31
  FDA 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…

• FDA approval · 2015-12-15
  FDA Approved: TACROLIMUS — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for tacrolimus submitted by Mylan Pharmaceuticals Inc.

• FDA approval · 2015-11-13
  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., updating the drug's label…

• FDA approval · 2015-11-13
  FDA 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…

• FDA approval · 2015-09-28
  FDA 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…

• FDA approval · 2015-08-04
  FDA Approved: MYFORTIC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for MYFORTIC (mycophenolic acid) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2015-05-28
  FDA 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…

• FDA approval · 2014-07-22
  FDA 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…

• FDA approval · 2013-09-27
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

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

• FDA approval · 2013-09-27
  FDA 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…

• FDA approval · 2013-09-04
  FDA 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…

• FDA approval · 2013-08-16
  FDA 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.

• FDA approval · 2013-07-19
  FDA 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…

• FDA approval · 2012-12-10
  FDA 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…

• FDA approval · 2012-09-25
  FDA 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…

• FDA approval · 2012-08-31
  FDA 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 …

• FDA approval · 2012-08-29
  FDA 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.

• FDA approval · 2012-06-08
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

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