Myocardial Infarction

• EMA approval · 2025-05-13
  EMA Authorised: Clopidogrel Krka d.d. (previously Zopya) (clopidogrel (as hydrochloride)) — Norpharm Regulatory Services Ltd

  The EMA authorised Clopidogrel Krka d.d. for indications including peripheral vascular disease, stroke, and myocardial infarction; the marke…

• EMA approval · 2025-05-13
  EMA Authorised: Clopidogrel TAD (clopidogrel (as hydrochloride)) — Tad Pharma GmbH

  EMA authorised Clopidogrel TAD (clopidogrel hydrochloride) by Tad Pharma GmbH for use in peripheral vascular diseases, stroke, and myocardia…

• EMA approval · 2025-05-05
  EMA Authorised: Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid Mylan) (acetylsalicylic acid;clopidogrel hydrogen sulfate) — Mylan Pharmaceuticals Limited

  EMA authorised a fixed-dose combination of clopidogrel and acetylsalicylic acid (Viatris) for acute coronary syndrome and myocardial infarct…

• FDA approval · 2025-05-02
  FDA Approved: TICAGRELOR — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves Alembic Pharmaceuticals' generic ticagrelor (ANDA 208576) under an original application. Ticagrelor is an antiplatelet medicati…

• EMA approval · 2025-05-02
  EMA Authorised: Eptifibatide Accord (eptifibatide) — Accord Healthcare S.L.U.

  Authorised in the EU: Accord Healthcare's Eptifibatide (eptifibatide) approved for use in myocardial infarction.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2025-03-24
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for metoprolol tartrate by Hikma Pharmaceuticals USA Inc. (ANDA 077761), updating the regulatory sta…

• FDA approval · 2025-03-17
  FDA Approved: ATENOLOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Atenolol from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2025-02-28
  FDA Approved: TNKASE — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for TNKASE (tenecteplase) from Genentech, resulting in an update to the product label.

• FDA approval · 2025-02-25
  FDA Approved: CLOPIDOGREL — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for clopidogrel filed by NorthStar RxLLC under an ANDA. The action indicates regulatory clearance fo…

• FDA approval · 2024-11-19
  FDA Approved: EPTIFIBATIDE — Supplemental Application (Slate Run Pharmaceuticals, LLC)

  FDA approved a supplemental application for the generic drug eptifibatide from Slate Run Pharmaceuticals, LLC, finalizing the regulatory act…

• FDA approval · 2024-11-12
  FDA Approved: METOPROLOL — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for metoprolol tartrate (metoprolol) from Baxter Healthcare Corporation. This document indicates the…

• FDA approval · 2024-10-29
  FDA Approved: TICAGRELOR — Original Application (Dr. Reddys Laboratories Inc)

  FDA approved Dr. Reddy's Laboratories' original application for ticagrelor (generic ticagrelor).

• FDA approval · 2024-10-24
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved Pfizer's supplemental application for Heparin Sodium, the anticoagulant. The approval updates the product's labeling/indication…

• FDA approval · 2024-09-25
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' supplemental application for metoprolol tartrate (metoprolol) under ANDA 202871, enabling a generic ve…

• FDA approval · 2024-09-24
  FDA Approved: CARVEDILOL — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for carvedilol by Sandoz Inc. This is a supplemental approval for a generic carvedilol product.

• FDA approval · 2024-09-19
  FDA Approved: ENALAPRIL MALEATE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the generic enalapril maleate from Rising Pharma Holdings under an Original Application (ANDA 218531).

• 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 · 2024-07-22
  FDA Approved: VALSARTAN — Original Application (Zydus Lifesciences Limited)

  FDA granted original approval for VALSARTAN (Valsartan) by Zydus Lifesciences Limited as a generic product under ANDA 218991.

• EMA approval · 2024-07-19
  EMA Authorised: DuoPlavin (clopidogrel;acetylsalicylic acid) — Sanofi Winthrop Industrie

  DuoPlavin, a fixed-dose combination of clopidogrel and acetylsalicylic acid, has been authorised by the EMA for treatment in acute coronary …

• FDA approval · 2024-07-08
  FDA Approved: CAPTOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for CAPTOPRIL (captopril), a generic ACE inhibitor.

• FDA approval · 2024-05-09
  FDA Approved: EPTIFIBATIDE — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals' original application (ANDA) for a generic version of eptifibatide (Integrilin). The approval permits …

• FDA approval · 2024-03-29
  FDA Approved: ATENOLOL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Atenolol by Aurobindo Pharma Limited, granting approval of a generic version under the ANDA proc…

• FDA approval · 2024-03-28
  FDA Approved: ATENOLOL — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for atenolol from Unichem Pharmaceuticals USA, Inc., granting an additional approval related to the …

• FDA approval · 2024-03-28
  FDA Approved: ATENOLOL — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for Atenolol by Ipca Laboratories Limited.

• EMA approval · 2024-03-26
  EMA Authorised: Clopidogrel ratiopharm (clopidogrel (as hydrogen sulfate)) — Teva B.V.

  European Medicines Agency authorises Clopidogrel ratiopharm (clopidogrel hydrogen sulfate) for multiple cardiovascular indications including…