Myocardial Infarction

• EMA approval · 2024-02-29
  EMA Authorised: Clopidogrel Teva (hydrogen sulphate) (clopidogrel (as hydrogen sulfate)) — Teva Pharma B.V.

  EMA authorised Clopidogrel Teva (hydrogen sulphate) for multiple cardiovascular indications including acute coronary syndrome, myocardial in…

• FDA approval · 2024-01-22
  FDA Approved: VALSARTAN — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application from Unichem Pharmaceuticals (USA), Inc. for valsartan (generic valsartan) under an ANDA.

• FDA approval · 2024-01-05
  FDA Approved: TNKASE — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for TNKASE (tenecteplase) from Genentech, Inc.

• 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.

• EMA approval · 2023-12-19
  EMA Authorised: Clopidogrel Taw Pharma (previously Clopidogrel Mylan) (clopidogrel hydrochloride) — Taw Pharma (Ireland) Limited

  EMA authorised a clopidogrel product (clopidogrel hydrochloride) by Taw Pharma (Ireland) Limited for peripheral vascular diseases, stroke, m…

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• FDA approval · 2023-11-22
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for metoprolol tartrate from Aurobindo Pharma Limited. The action confirms approval of changes to an…

• FDA approval · 2023-09-07
  FDA Approved: CLOPIDOGREL — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for clopidogrel bisulfate (generic clopidogrel) by Apotex Corp., under the ANDA, authorizing a modif…

• FDA approval · 2023-07-05
  FDA Approved: LOPRESSOR — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for Lopressor (metoprolol tartrate) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2023-06-08
  FDA Approved: CLOPIDOGREL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for a generic clopidogrel product from Aurobindo Pharma Limited.

• EMA approval · 2023-06-01
  EMA Authorised: Rapilysin (reteplase) — Actavis Group PTC ehf

  Rapilysin (reteplase) has been authorised in the EU for myocardial infarction, with Actavis Group PTC ehf as the marketing authorisation hol…

• 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 · 2023-04-21
  FDA Approved: TICAGRELOR — Original Application (Ascend Laboratories, LLC)

  FDA approved Ticagrelor under an Original Application by Ascend Laboratories, LLC. The approval supports its use as an antiplatelet therapy …

• FDA approval · 2023-03-31
  FDA Approved: TNKASE — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for TNKASE (tenecteplase) from Genentech, Inc.

• FDA approval · 2023-01-27
  FDA Approved: CAPTOPRIL — Original Application (AiPing Pharmaceutical, Inc.)

  The FDA approved AiPing Pharmaceutical’s Original Application for CAPTOPRIL (captopril), a generic ACE inhibitor. The approval supports indi…

• FDA approval · 2022-11-15
  FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Amphastar Pharmaceuticals, Inc.)

  FDA approves Amphastar Pharmaceuticals' supplemental application for enoxaparin sodium.

• FDA approval · 2022-09-16
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Inc)

  FDA approves a supplemental application for clopidogrel bisulfate from Dr. Reddy's Laboratories Inc, pertaining to the approved generic prod…

• FDA approval · 2022-09-12
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical Industries’ supplemental application for clopidogrel bisulfate, indicating regulatory approval of change…

• FDA approval · 2022-07-21
  FDA Approved: VALSARTAN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for VALSARTAN from Amneal Pharmaceuticals LLC.

• FDA approval · 2022-06-30
  FDA Approved: RAMIPRIL — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for ramipril submitted by Zydus Lifesciences Limited under ANDA078832.

• FDA approval · 2022-06-29
  FDA Approved: ENALAPRIL MALEATE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approves the original generic application for enalapril maleate (Enalapril) manufactured by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2022-03-31
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (RADHA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for clopidogrel bisulfate (Radha Pharmaceuticals, Inc.) under an ANDA, confirming its status as a ge…

• EMA approval · 2022-03-17
  EMA Authorised: Integrilin (eptifibatide) — GlaxoSmithKline Trading Services Limited

  Authorised by EMA: Integrilin (eptifibatide) approved for unstable angina and myocardial infarction.

• FDA approval · 2022-02-15
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for Heparin Sodium submitted by Sandoz Inc., indicating an additional regulatory action on this gene…

• FDA approval · 2022-01-12
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for HEPARIN SODIUM from Sagent Pharmaceuticals, authorizing changes under an approved supplemental f…

• FDA approval · 2022-01-12
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for Heparin Sodium from Sagent Pharmaceuticals, confirming regulatory status and updates related to …