Heart Transplant

• CLINICAL_TRIALS trial_result · 2020-02-11
  Clinical Trial Update: Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels [Phase 4]

  A Phase 4 clinical trial update from Nordic Study evaluating outcomes in heart and lung transplant recipients in relation to cyclosporine mi…

• 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…

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• CLINICAL_TRIALS trial_result · 2017-01-10
  Clinical Trial Update: Prospective L-arginine Study [Phase 1]

  Phase 1 prospective study of L-arginine in heart transplant patients was terminated.

• CLINICAL_TRIALS research · 2015-09-22
  Clinical Trial Update: Impact of Stress Management Training After Cardiac Transplantation [Phase 3]

  Phase 3 clinical trial evaluating the impact of stress management training in heart transplant recipients.

• 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…

• FDA approval · 2009-02-27
  FDA Approved: CELLCEPT — Supplemental Application (Genentech, Inc.)

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

• CLINICAL_TRIALS research · 2008-10-17
  Clinical Trial Update: Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms [Phase 3]

  Phase 3 clinical trial update of Myfortic (mycophenolate mofetil) in heart transplant patients with GI symptoms. The current status of the t…