Myocardial Ischemia

• EMA approval · 2025-12-17
  EMA Authorised: Rapiscan (regadenoson) — GE Healthcare AS

  The European Medicines Agency authorised Rapiscan, a regadenoson-based diagnostic radiopharmaceutical from GE Healthcare AS, for use in myoc…

• FDA approval · 2024-09-27
  FDA Approved: FLYRCADO — Original Application (GE Healthcare Inc.)

  FDA approves FLYRCADO (FLURPIRIDAZ F-18) from GE Healthcare Inc. as a PET imaging radiotracer for myocardial perfusion imaging under the Ori…

• FDA approval · 2023-02-02
  FDA Approved: REGADENOSON — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Hikma Pharmaceuticals USA Inc. for Regadenoson (ANDA 215827) as a generic injectable pharmacologic stress agent for myocardial …

• FDA approval · 2022-10-26
  FDA Approved: REGADENOSON — Original Application (Eugia US LLC)

  FDA approved Regadenoson via an original application for Eugia US LLC (ANDA216437), enabling a generic version of Regadenoson for pharmacolo…

• FDA approval · 2022-07-12
  FDA Approved: REGADENOSON — Original Application (Almaject, Inc.)

  The FDA approved Almaject, Inc.'s original Abbreviated New Drug Application for regadenoson, a pharmacologic stress agent used in myocardial…

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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 · 2015-10-19
  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 · 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 · 2011-06-22
  FDA Approved: THALLOUS CHLORIDE TL 201 — Supplemental Application (Curium US LLC)

  FDA approved a supplemental application for Thallous chloride TL 201 from Curium US LLC, indicating an updated or expanded regulatory cleara…

• FDA approval · 2008-04-30
  FDA Approved: CARDIOLITE — Supplemental Application (Lantheus Medical Imaging, Inc.)

  FDA approved a supplemental application for Cardiolite, updating its labeling and regulatory status for the radiopharmaceutical used in myoc…

• FDA approval · 2007-08-23
  FDA Approved: AMMONIA N 13 — Original Application (THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH)

  FDA approved AMMONIA N 13 (NH3N13), an ammonia-13 radiopharmaceutical for PET imaging, derived from the original NDA submitted by The Feinst…