Ischemic Heart Disease

• FDA approval · 2023-05-25
  FDA Approved: EPTIFIBATIDE — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for the generic drug Eptifibatide filed by Eugia US LLC (ANDA 206127).

• FDA approval · 2023-05-12
  FDA Approved: AMMONIA N 13 — Supplemental Application (SOFIE Co. dba SOFIE)

  FDA approved a supplemental application for Ammonia N-13 (AMMONIA N-13) from SOFIE Co. dba SOFIE, updating its regulatory approval. This app…

• FDA approval · 2023-04-25
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for atorvastatin calcium by Dr. Reddy's Laboratories Limited.

• FDA approval · 2023-04-12
  FDA Approved: PRASUGREL — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for the generic prasugrel from Accord Healthcare Inc., finalizing a regulatory action under the ANDA…

• FDA approval · 2023-02-23
  FDA Approved: EPTIFIBATIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for the generic Eptifibatide from Mylan Institutional LLC. The approval updates the product's regula…

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• 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 · 2022-12-06
  FDA Approved: MYOVIEW — Supplemental Application (Medi-Physics Inc. dba GE Healthcare)

  FDA approved a supplemental application for MYOVIEW (tetrofosmin) submitted by Medi-Physics Inc. dba GE Healthcare.

• FDA approval · 2022-11-03
  FDA Approved: AMMONIA N 13 — Original Application (University of Alabama at Birmingham)

  FDA approved the original application for Ammonia N-13 (NH3N13), a radiopharmaceutical imaging agent developed by the University of Alabama …

• 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 · 2022-08-31
  FDA Approved: REGADENOSON — Original Application (Hospira, Inc.)

  FDA approved Hospira's Regadenoson as a generic (ANDA 214349) for use as a pharmacologic stress agent to detect myocardial ischemia in patie…

• 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…

• FDA approval · 2022-05-23
  FDA Approved: REGADENOSON — Original Application (International Medication Systems, Limited)

  FDA approved an original ANDA for Regadenoson by International Medication Systems, Limited, authorizing a generic regadenoson product for us…

• FDA approval · 2022-05-17
  FDA Approved: TECHNETIUM TC 99M SESTAMIBI — Supplemental Application (Curium US LLC)

  FDA approved a supplemental application for Technetium Tc-99m Sestamibi, updating its labeling and approved use in diagnostic myocardial per…

• FDA approval · 2022-04-11
  FDA Approved: REGADENOSON — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s generic Regadenoson for use as a pharmacologic stress agent in myocardial perfusion imaging to evaluate for coro…

• FDA approval · 2022-04-11
  FDA Approved: REGADENOSON — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved the original application for Regadenoson from Dr. Reddy's Laboratories Inc. as a generic product for pharmacologic stress testi…

• FDA approval · 2022-04-11
  FDA Approved: REGADENOSON — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals' original (ANDA) application for Regadenoson, a generic pharmacologic stress agent used for myocardial…

• FDA approval · 2022-03-09
  FDA Approved: MYOVIEW — Supplemental Application (Medi-Physics Inc. dba GE Healthcare)

  FDA approved a supplemental application for MYOVIEW (tetrofosmin) by Medi-Physics Inc. dba GE Healthcare, authorizing an updated use of the …

• FDA approval · 2022-01-26
  FDA Approved: ISOSORBIDE MONONITRATE — Supplemental Application (Edenbridge Pharmaceuticals LLC.)

  FDA approved a supplemental application for Edenbridge Pharmaceuticals' generic Isosorbide Mononitrate.

• FDA approval · 2021-12-21
  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. The action confirms approva…

• FDA approval · 2021-03-05
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Accord Healthcare's generic pravastatin sodium, updating its regulatory status as an approved ge…

• FDA approval · 2021-01-15
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for atorvastatin calcium (generic atorvastatin) manufactured by Mylan Pharmaceuticals Inc.

• FDA approval · 2020-12-22
  FDA Approved: EFFIENT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for EFFIENT (prasugrel hydrochloride) submitted by Cosette Pharmaceuticals, Inc.

• FDA approval · 2020-12-15
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for the fixed-dose combination of amlodipine besylate and atorvastatin calcium, manufactured by …

• FDA approval · 2020-11-25
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories, LLC's metoprolol succinate extended-release tablets as an original application (generic).

• FDA approval · 2020-06-24
  FDA Approved: AMMONIA N 13 — Supplemental Application (3D Imaging Drug Design and Development LLC)

  FDA approved a supplemental application for AMMONIA N 13, a PET imaging radiopharmaceutical, submitted by 3D Imaging Drug Design and Develop…