Organ Transplantation

• FDA approval · 2025-09-04
  FDA Approved: TACROLIMUS — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application from Amneal Pharmaceuticals NY LLC for tacrolimus and tacrolimus extended-release capsules, expa…

• 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…

• EMA approval · 2025-02-28
  EMA Authorised: Envarsus (tacrolimus) — Chiesi Farmaceutici S.p.A.

  The EMA authorised Envarsus (tacrolimus) by Chiesi Farmaceutici S.p.A. for prevention of graft rejection in organ transplantation.

• EMA approval · 2025-02-27
  EMA Authorised: Advagraf (tacrolimus) — Astellas Pharma Europe BV

  The EMA authorized Advagraf (tacrolimus) by Astellas Pharma Europe BV for prevention of graft rejection in organ transplant recipients.

• FDA approval · 2023-09-26
  FDA Approved: NEORAL — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

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• FDA approval · 2022-11-22
  FDA Approved: ASTAGRAF XL — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA granted approval for a supplemental application for ASTAGRAF XL (tacrolimus extended-release capsules) to update/expand its labeling…

• FDA approval · 2021-09-23
  FDA Approved: MYCOPHENOLIC ACID — Original Application (Ascend Laboratories, LLC)

  FDA approved the original application for generic mycophenolic acid by Ascend Laboratories, authorizing its use to prevent organ transplant …

• FDA approval · 2021-08-11
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)

  The FDA approved a supplemental application for mycophenolate mofetil from Concord Biotech Limited, resulting in approval of this generic im…

• FDA approval · 2021-08-11
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)

  FDA approved a supplemental application for a generic version of mycophenolate mofetil from Concord Biotech Limited.

• FDA approval · 2020-08-04
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for a generic version of mycophenolate mofetil from Strides Pharma Science Limited.

• 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 · 2013-01-28
  FDA Approved: PROGRAF — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for PROGRAF (tacrolimus) submitted by Astellas Pharma US, Inc., related to updating/expanding it…

• FDA approval · 2012-08-30
  FDA Approved: SANDIMMUNE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for SANDIMMUNE (cyclosporine) to update and expand its labeling.

• FDA approval · 2007-12-27
  FDA Approved: CYCLOSPORINE — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application for cyclosporine from Apotex Corp. This action approves additional labeling or supply under the supp…