Kidney Transplant

• FDA approval · 2025-07-15
  FDA Approved: SIROLIMUS — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved Rising Pharma Holdings, Inc.'s original application for sirolimus, a generic immunosuppressant used to prevent organ transp…

• FDA approval · 2024-09-26
  FDA Approved: MYCOPHENOLATE MOFETIL — Original Application (Aurobindo Pharma Limited)

  The FDA approved the original application for mycophenolate mofetil from Aurobindo Pharma Limited, granting generic approval for use in tran…

• FDA approval · 2024-09-20
  FDA Approved: TACROLIMUS — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for tacrolimus by Mylan Pharmaceuticals Inc., enabling changes to its labeling. This relates to …

• FDA approval · 2024-05-29
  FDA Approved: MYCOPHENOLIC ACID — Original Application (Novugen Pharma (USA) LLC.)

  FDA approved an original application for mycophenolic acid, enabling a generic version of the immunosuppressant used to prevent organ transp…

• FDA approval · 2024-04-08
  FDA Approved: ENVARSUS XR — Supplemental Application (Veloxis Pharmaceuticals, Inc)

  FDA approved a supplemental application for ENVARSUS XR (tacrolimus extended-release) submitted by Veloxis Pharmaceuticals, Inc.

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• FDA approval · 2023-09-18
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Accord Healthcare Inc.)

  The FDA approved a supplemental application for Accord Healthcare's generic mycophenolate mofetil, supporting its use to prevent organ trans…

• FDA approval · 2023-09-14
  FDA Approved: ENVARSUS XR — Supplemental Application (Veloxis Pharmaceuticals, Inc)

  FDA approved a supplemental application for ENVARSUS XR (tacrolimus) from Veloxis Pharmaceuticals, Inc., typically affecting the product's l…

• FDA approval · 2021-08-11
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for CELLCEPT (mycophenolate mofetil hydrochloride) submitted by Genentech, authorizing an update to …

• FDA approval · 2021-08-11
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for Mycophenolate mofetil submitted by Strides Pharma Science Limited. The approval covers the gener…

• FDA approval · 2021-04-21
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Hikma Pharmaceuticals USA Inc.'s supplemental application for Mycophenolate mofetil, a generic immunosuppressant used to preven…

• FDA approval · 2021-03-12
  FDA Approved: SIROLIMUS — Original Application (Ascend Laboratories, LLC)

  FDA approves the original (generic) application for sirolimus from Ascend Laboratories, authorizing its marketing as an immunosuppressant. T…

• FDA approval · 2021-01-15
  FDA Approved: MYFORTIC — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Myfortic (mycophenolic acid) submitted by Novartis Pharmaceuticals Corporation. The approval typ…

• FDA approval · 2021-01-15
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for mycophenolate mofetil (generic) submitted by Mylan Institutional LLC.

• FDA approval · 2019-06-11
  FDA Approved: ASTAGRAF XL — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for ASTAGRAF XL (tacrolimus extended-release capsules) submitted by Astellas Pharma US, Inc., approv…

• FDA approval · 2019-02-27
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

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

• FDA approval · 2018-12-19
  FDA Approved: ENVARSUS XR — Supplemental Application (Veloxis Pharmaceuticals, Inc)

  The FDA approved a supplemental application for ENVARSUS XR (Tacrolimus) submitted by Veloxis Pharmaceuticals, Inc.

• FDA approval · 2018-04-16
  FDA Approved: TACROLIMUS — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark Pharmaceuticals' generic tacrolimus (ANDA210393) as an original application, enabling its use to prevent organ tra…

• FDA approval · 2016-06-13
  FDA Approved: ENVARSUS XR — Supplemental Application (Veloxis Pharmaceuticals, Inc)

  FDA approved a supplemental application for ENVARSUS XR (tacrolimus) from Veloxis Pharmaceuticals, Inc.

• FDA approval · 2015-12-16
  FDA Approved: ASTAGRAF XL — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for ASTAGRAF XL (tacrolimus extended-release capsules) to support an expanded use in preventing …

• FDA approval · 2014-02-11
  FDA Approved: ASTAGRAF XL — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for ASTAGRAF XL (tacrolimus extended-release capsules) from Astellas Pharm US, Inc.

• FDA approval · 2013-02-08
  FDA Approved: MYFORTIC — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2012-09-25
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for mycophenolate mofetil submitted by Sandoz Inc.

• FDA approval · 2012-06-27
  FDA Approved: TACROLIMUS — Supplemental Application (Sandoz Inc.)

  The FDA approved a supplemental application for tacrolimus from Sandoz Inc. The approval enables the marketing of a generic tacrolimus produ…

• FDA approval · 2010-01-25
  FDA Approved: SIROLIMUS — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for sirolimus submitted by Mylan Pharmaceuticals Inc., updating the drug's status.

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

  FDA approved Accord Healthcare's original application for mycophenolate mofetil, an immunosuppressant used to prevent organ transplant rejec…