Ischemic Heart Disease

• FDA approval · 2016-05-11
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for CLOPIDOGREL BISULFATE submitted by Dr. Reddy's Laboratories Limited.

• FDA approval · 2016-04-11
  FDA Approved: FLUDEOXYGLUCOSE F18 — Original Application (Kreitchman PET Center)

  The FDA approved Fludeoxyglucose F18 through an Original Application filed by Kreitchman PET Center for use as a radiopharmaceutical in PET …

• FDA approval · 2016-03-21
  FDA Approved: BIVALIRUDIN — Supplemental Application (Civica, Inc.)

  FDA approved a Civica, Inc.-submitted supplemental application for Bivalirudin, updating its regulatory status for use as an anticoagulant. …

• FDA approval · 2016-03-02
  FDA Approved: KENGREAL — Supplemental Application (Chiesi USA, Inc.)

  FDA approved a supplemental application for KENGREAL (cangrelor) from Chiesi USA, Inc., resulting in an updated labeling for the product.

• FDA approval · 2016-02-26
  FDA Approved: FLUDEOXYGLUCOSE F 18 — Supplemental Application (Massachusetts General Hospital)

  FDA approved a supplemental application for Fludeoxyglucose F-18 submitted by Massachusetts General Hospital to support its use as a radioph…

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• FDA approval · 2016-02-03
  FDA Approved: AMMONIA N 13 — Original Application (Massachusetts General Hospital)

  FDA approves the original application for Ammonia N-13, a radiopharmaceutical used in PET imaging to assess myocardial perfusion in suspecte…

• FDA approval · 2015-11-02
  FDA Approved: AMMONIA N 13 — Original Application (PETNET Solutions, Inc.)

  FDA approved Ammonia N-13 from PETNET Solutions as an original-application radiopharmaceutical for PET imaging to assess myocardial perfusio…

• FDA approval · 2015-10-30
  FDA Approved: FLUDEOXYGLUCOSE F18 — Original Application (3D Imaging Drug Design and Development LLC)

  FDA approved Fluorodeoxyglucose F18 (FDG F-18) as an original radiopharmaceutical for PET imaging to assess metabolic activity in oncology, …

• FDA approval · 2015-10-27
  FDA Approved: FLUDEOXYGLUCOSE F 18 — Original Application (Kettering Medical Center)

  FDA approved Fludeoxyglucose F-18 (FDG F-18) under an Original Application by Kettering Medical Center for use as a PET imaging radiopharmac…

• FDA approval · 2015-10-19
  FDA Approved: AMMONIA N 13 — Original Application (3D Imaging Drug Design and Development LLC)

  FDA approved AMMONIA N-13 for PET myocardial perfusion imaging under an Original Application from 3D Imaging Drug Design and Development LLC…

• FDA approval · 2015-08-14
  FDA Approved: AMMONIA N-13 — Original Application (Precision Nuclear LLC)

  FDA approves AMMONIA N-13 from Precision Nuclear LLC through an Original Application for use as a PET radiotracer.

• FDA approval · 2015-06-24
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approves a supplemental application for Brilinta (ticagrelor) from AstraZeneca. The approval updates Brilinta's labeling as described in…

• FDA approval · 2015-06-23
  FDA Approved: FLUDEOXYGLUCOSE F 18 — Original Application (The University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute)

  FDA approved the original application for Fludeoxyglucose F-18 as a radiopharmaceutical imaging agent for PET scans, developed by the Univer…

• FDA approval · 2015-06-22
  FDA Approved: KENGREAL — Original Application (Chiesi USA, Inc.)

  The FDA approved KENGREAL (cangrelor) in its original application from Chiesi USA, Inc., authorizing its use as an intravenous antiplatelet …

• FDA approval · 2015-06-17
  FDA Approved: NITROGLYCERIN IN DEXTROSE — Supplemental Application (Baxter Healthcare Company)

  FDA approved Baxter's supplemental application for Nitroglycerin in Dextrose, approving a nitroglycerin-in-dextrose intravenous formulation …

• FDA approval · 2015-04-09
  FDA Approved: TECHNETIUM TC 99M SESTAMIBI — Supplemental Application (Curium US LLC)

  FDA approved a supplemental application for Technetium Tc-99m Sestamibi (Curium US LLC), updating its approval-related labeling.

• FDA approval · 2015-01-23
  FDA Approved: NITROGLYCERIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for nitroglycerin submitted by Prasco Laboratories under the existing NDA.

• FDA approval · 2014-12-05
  FDA Approved: CARDIOGEN-82 — Supplemental Application (Bracco Diagnostics Inc)

  FDA approved a supplemental application for CardioGen-82 (rubidium chloride RB-82) from Bracco Diagnostics Inc.

• FDA approval · 2014-11-05
  FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare, Inc.'s supplemental application for simvastatin (generic statin).

• FDA approval · 2014-11-05
  FDA Approved: SIMVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for simvastatin, updating the approved generic product.

• FDA approval · 2014-10-30
  FDA Approved: AMMONIA N-13 — Original Application (Brigham and Women's Hospital, Inc., The)

  FDA approved Ammonia N-13 under an original application from Brigham and Women's Hospital for use as a radiopharmaceutical in PET myocardial…

• FDA approval · 2014-08-19
  FDA Approved: AMMONIA N 13 — Original Application (The Johns Hopkins University)

  FDA approved AMMONIA N 13 (NH3N13) via an Original Application under an ANDA from The Johns Hopkins University, for use as a radiopharmaceut…

• FDA approval · 2014-07-28
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application from Prasco Laboratories for the fixed-dose combination of amlodipine and atorvastatin (amlodipi…

• FDA approval · 2014-04-11
  FDA Approved: CLOPIDOGREL — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's original application for clopidogrel, enabling a generic version of the antiplatelet medicatio…

• FDA approval · 2014-03-28
  FDA Approved: AMMONIA N 13 — Original Application (UCSF Radiopharmaceutical Facility)

  The FDA approved Ammonia N-13 (NH3N13) from the UCSF Radiopharmaceutical Facility under an Original Application.