Ischemic Heart Disease

• 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 · 2025-12-10
  FDA Approved: THALLOUS CHLORIDE TL 201 — Supplemental Application (Curium US LLC)

  The FDA approved a supplemental application for Thallous Chloride TL 201 by Curium US LLC, updating its regulatory status for use as a radio…

• FDA approval · 2025-10-28
  FDA Approved: TICAGRELOR — Original Application (Dr. Reddys Laboratories Inc)

  FDA approved Dr. Reddy's Laboratories' original application for ticagrelor as a generic version of the antiplatelet drug, expanding access t…

• FDA approval · 2025-10-28
  FDA Approved: TICAGRELOR — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s original application for a ticagrelor generic.

• FDA approval · 2025-10-28
  FDA Approved: TICAGRELOR — Original Application (Radha Pharmaceuticals INC)

  FDA approves Radha Pharmaceuticals INC's original ANDA for Ticagrelor, a generic antiplatelet medication.

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• FDA approval · 2025-06-24
  FDA Approved: CARVEDILOL PHOSPHATE — Supplemental Application (AvKARE)

  FDA approved a supplemental application for carvedilol phosphate submitted by AvKARE. This action approves a generic carvedilol phosphate pr…

• FDA approval · 2025-04-15
  FDA Approved: NITROGLYCERIN — Original Application (Encube Ethicals, Inc.)

  FDA approves Encube Ethicals, Inc.'s nitroglycerin product under an Original Application (ANDA). This expands access to a generic nitroglyce…

• FDA approval · 2025-03-19
  FDA Approved: CARVEDILOL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for carvedilol from Quallent Pharmaceuticals Health LLC.

• FDA approval · 2025-01-15
  FDA Approved: EPTIFIBATIDE — Supplemental Application (Baxter Healthcare Company)

  FDA approved Baxter Healthcare's supplemental application for eptifibatide (brand Integrilin). This notice reflects a supplemental approval …

• FDA approval · 2024-12-23
  FDA Approved: CARDIOGEN-82 — Supplemental Application (Bracco Diagnostics Inc)

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

• FDA approval · 2024-12-16
  FDA Approved: NITROGLYCERIN — Original Application (Encube Ethicals, Inc.)

  The FDA approved Encube Ethicals, Inc.'s generic nitroglycerin product under an Original Application (ANDA216452). This approval provides a …

• 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 · 2024-08-16
  FDA Approved: TICAGRELOR — Original Application (Solco Healthcare U.S., LLC)

  The FDA approved a generic ticagrelor product under an original Abbreviated New Drug Application submitted by Solco Healthcare U.S., LLC.

• FDA approval · 2024-07-26
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Oryza pharmaceuticals Inc.)

  FDA approved a generic metoprolol succinate product from Oryza Pharmaceuticals Inc. via an Original Application (ANDA).

• FDA approval · 2024-06-28
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (BluePoint Laboratories)

  FDA approves a supplemental application for metoprolol succinate from BluePoint Laboratories to bring a generic version to market.

• FDA approval · 2024-03-01
  FDA Approved: DEFINITY — Supplemental Application (Lantheus Medical Imaging, Inc.)

  FDA approved a supplemental application for DEFINITY (perflutren) from Lantheus Medical Imaging, Inc., resulting in updated labeling and/or …

• FDA approval · 2024-02-16
  FDA Approved: NITROGLYCERIN — Original Application (Cosette Pharmaceuticals, Inc.)

  FDA approves Cosette Pharmaceuticals' generic nitroglycerin under an original ANDA.

• FDA approval · 2023-12-27
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for metoprolol succinate (Toprol-XL) under an ANDA from Nivagen Pharmaceuticals.

• FDA approval · 2023-12-22
  FDA Approved: TENORMIN — Supplemental Application (Almatica Pharma LLC)

  FDA approves a supplemental application for Tenormin (atenolol) filed by Almatica Pharma LLC.

• FDA approval · 2023-12-05
  FDA Approved: NITROGLYCERIN — Original Application (Lifestar Pharma LLC)

  FDA approved an original application for nitroglycerin from Lifestar Pharma LLC, enabling a generic nitroglycerin product.

• FDA approval · 2023-10-26
  FDA Approved: NITROGLYCERIN — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for nitroglycerin by Aurobindo Pharma Limited, a generic version of the drug.

• FDA approval · 2023-09-12
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for metoprolol succinate from Mylan Pharmaceuticals Inc.

• FDA approval · 2023-08-09
  FDA Approved: ZOCOR — Supplemental Application (Organon LLC)

  FDA approved a Supplemental Application for ZOCOR (simvastatin) submitted by Organon LLC.

• FDA approval · 2023-06-06
  FDA Approved: NITROGLYCERIN — Supplemental Application (Dr. Reddys Laboratories Inc)

  FDA approved a supplemental application for nitroglycerin submitted by Dr. Reddys Laboratories Inc.

• FDA approval · 2023-06-05
  FDA Approved: DEFINITY — Supplemental Application (Lantheus Medical Imaging, Inc.)

  FDA approved a supplemental application for DEFINITY (perflutren) submitted by Lantheus Medical Imaging, Inc.