Myocardial Infarction

• FDA approval · 2020-07-15
  FDA Approved: HEPARIN SODIUM — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals' generic heparin sodium (Original Application) as an injectable anticoagulant. It covers the same indi…

• FDA approval · 2020-07-10
  FDA Approved: VALSARTAN — Supplemental Application (Solco Healthcare US, LLC)

  FDA approved a supplemental application for VALSARTAN by Solco Healthcare US, LLC.

• FDA approval · 2020-05-05
  FDA Approved: VALSARTAN — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  The FDA approved Jubilant Cadista's supplemental application for the generic drug valsartan. Valsartan is used to treat hypertension, heart …

• FDA approval · 2020-04-29
  FDA Approved: LISINOPRIL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901))

  FDA approved a supplemental application for lisinopril from Heritage Pharmaceuticals d/b/a Avet Pharmaceuticals, advancing an update to an e…

• FDA approval · 2020-04-27
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  FDA approved a supplemental application for lisinopril from Solco Healthcare U.S., LLC, approving a generic lisinopril product.

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• FDA approval · 2020-04-27
  FDA Approved: LISINOPRIL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for lisinopril submitted by Quallent Pharmaceuticals Health LLC.

• FDA approval · 2020-04-14
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for Enalapril maleate from Northstar RxLLC under an ANDA.

• FDA approval · 2020-04-07
  FDA Approved: TICAGRELOR — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved the original application for ticagrelor from Novadoz Pharmaceuticals LLC. Ticagrelor is an antiplatelet medication used to redu…

• FDA approval · 2020-04-06
  FDA Approved: TICAGRELOR — Original Application (Oryza Pharmaceuticals, Inc.)

  FDA approved the original application for ticagrelor by Oryza Pharmaceuticals, Inc., authorizing a generic ticagrelor product. Ticagrelor is…

• FDA approval · 2020-04-02
  FDA Approved: HEPARIN SODIUM — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals' original application for a generic heparin sodium product.

• EMA approval · 2020-03-11
  EMA Authorised: Clopidogrel BGR (previously Zylagren) (clopidogrel (as hydrogen sulfate)) — Biogaran

  European Medicines Agency authorised Clopidogrel BGR (clopidogrel as hydrogen sulfate) by Biogaran for peripheral vascular diseases, stroke,…

• FDA approval · 2020-02-05
  FDA Approved: TICAGRELOR — Supplemental Application (Hisun Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Ticagrelor from Hisun Pharmaceuticals USA, Inc., confirming approval of the generic ticagrel…

• FDA approval · 2019-12-13
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (RADHA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for Clopidogrel Bisulfate from Radha Pharmaceuticals, Inc., confirming approval of their generic pro…

• FDA approval · 2019-12-13
  FDA Approved: CAPTOPRIL — Original Application (Ajanta Pharma USA Inc.)

  This document reports the FDA approval of CAPTOPRIL as a generic product (Original Application) by Ajanta Pharma USA Inc.

• EMA approval · 2019-11-13
  EMA Authorised: Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover) (clopidogrel;acetylsalicylic acid) — Sanofi-Aventis Groupe

  European Medicines Agency authorised a clopidogrel and acetylsalicylic acid combination product (Zentiva/DuoCover) for acute coronary syndro…

• FDA approval · 2019-11-06
  FDA Approved: CLOPIDOGREL — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's supplemental application for clopidogrel under ANDA090844, finalizing an approval for its gen…

• FDA approval · 2019-11-06
  FDA Approved: VALSARTAN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for valsartan from Ascend Laboratories, updating the regulatory status of this generic antihypertens…

• FDA approval · 2019-11-04
  FDA Approved: PRASUGREL — Supplemental Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's supplemental application for prasugrel (generic) under ANDA205987, granting approval for the generic prasug…

• FDA approval · 2019-10-30
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for metoprolol tartrate by Hospira, Inc. under ANDA 078085, finalizing changes to the generic produc…

• FDA approval · 2019-10-24
  FDA Approved: METOPROLOL — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved Baxter Healthcare Corporation's supplemental application for Metoprolol Tartrate under ANDA 078950. This approval updates a…

• FDA approval · 2019-09-26
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  The FDA approved a supplemental application for lisinopril filed by Solco Healthcare U.S., LLC under an ANDA. The action authorizes changes …

• FDA approval · 2019-09-23
  FDA Approved: BIVALIRUDIN — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for Bivalirudin submitted by Mylan Institutional LLC.

• FDA approval · 2019-09-23
  FDA Approved: BIVALIRUDIN — Supplemental Application (Meitheal Pharmaceuticals Inc.)

  FDA approved a supplemental application for bivalirudin by Meitheal Pharmaceuticals, marking regulatory approval of a modification to the dr…

• FDA approval · 2019-09-20
  FDA Approved: CLOPIDOGREL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for clopidogrel bisulfate manufactured by Aurobindo Pharma Limited, enabling continued marketing…

• FDA approval · 2019-09-20
  FDA Approved: VALSARTAN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves a supplemental application for VALSARTAN by Amneal Pharmaceuticals LLC (ANDA 204011) to support the generic product.