Coronary Syndrome

• FDA approval · 2019-04-03
  FDA Approved: CLOPIDOGREL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for clopidogrel bisulfate from Aurobindo Pharma Limited, confirming regulatory approval for this gen…

• FDA approval · 2019-03-28
  FDA Approved: EFFIENT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for EFFIENT (prasugrel hydrochloride) from Cosette Pharmaceuticals, Inc., indicating updates to the …

• FDA approval · 2019-03-14
  FDA Approved: ENOXAPARIN SODIUM — Original Application (Amphastar Pharmaceuticals, Inc.)

  FDA approved Amphastar Pharmaceuticals' generic enoxaparin sodium injection (ANDA 208600). This marks approval of a generic version of enoxa…

• FDA approval · 2019-01-23
  FDA Approved: TICAGRELOR — Original Application (Hisun Pharmaceuticals USA, Inc.)

  The FDA approved an Original Application (ANDA) for ticagrelor from Hisun Pharmaceuticals USA, Inc., enabling a generic ticagrelor product t…

• FDA approval · 2018-12-21
  FDA Approved: BIVALIRUDIN — Supplemental Application (Civica, Inc.)

  The FDA approved a supplemental application for BIVALIRUDIN from Civica, Inc., resulting in an approved update to the NDA.

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• FDA approval · 2018-12-20
  FDA Approved: HEPARIN SODIUM AND DEXTROSE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Hospira's Heparin Sodium and Dextrose (heparin sodium) product, authorizing changes under the ND…

• FDA approval · 2018-12-14
  FDA Approved: HEPARIN SODIUM — Original Application (NorthStar RxLLC)

  The FDA approved NorthStar RxLLC's original application for generic heparin sodium (ANDA211005).

• FDA approval · 2018-12-11
  FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approves a Supplemental Application for enoxaparin sodium from Sanofi-Aventis U.S. LLC to update the product labeling.

• FDA approval · 2018-11-23
  FDA Approved: EPTIFIBATIDE — Original Application (Baxter Healthcare Company)

  FDA approval of Baxter Healthcare's original ANDA for eptifibatide (EPTIFIBATIDE), a generic injectable antiplatelet agent.

• FDA approval · 2018-09-04
  FDA Approved: TICAGRELOR — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approves Teva's generic ticagrelor (ANDA 208390) as an original application approval for TICAGRELOR.

• EMA approval · 2018-08-01
  EMA Authorised: Clopidogrel HCS (clopidogrel (as hydrochloride)) — HCS bvba

  The EMA authorised Clopidogrel HCS (clopidogrel hydrochloride) for several cardiovascular indications including peripheral vascular diseases…

• FDA approval · 2018-07-16
  FDA Approved: BIVALIRUDIN — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals' original application for generic bivalirudin.

• FDA approval · 2018-06-19
  FDA Approved: PRASUGREL — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original application for prasugrel, authorizing a generic version of the antiplatelet medication. …

• FDA approval · 2018-06-01
  FDA Approved: BIVALIRUDIN — Original Application (Mylan Institutional LLC)

  FDA approved the original abbreviated new drug application for bivalirudin from Mylan Institutional LLC, enabling the marketing of a generic…

• FDA approval · 2018-05-25
  FDA Approved: PLAVIX — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for Plavix (clopidogrel) submitted by Sanofi-Aventis U.S. LLC. The approval indicates regulatory…

• FDA approval · 2018-03-09
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Brilinta (ticagrelor) submitted by AstraZeneca Pharmaceuticals LP.

• FDA approval · 2018-03-09
  FDA Approved: EFFIENT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2018-03-07
  FDA Approved: EPTIFIBATIDE — Original Application (Sagent Pharmaceuticals)

  FDA approved EPTIFIBATIDE from Sagent Pharmaceuticals via an Original Application, marking regulatory approval for this product.

• FDA approval · 2018-02-02
  FDA Approved: PRASUGREL — Original Application (Accord Healthcare Inc.)

  The FDA approved Accord Healthcare Inc.'s original ANDA for a generic prasugrel product, expanding access to this antiplatelet therapy used …

• FDA approval · 2017-11-30
  FDA Approved: HEPARIN SODIUM — Original Application (Mylan Institutional LLC)

  FDA approved an Original Application for HEPARIN SODIUM (generic) from Mylan Institutional LLC, authorizing marketing of this anticoagulant.…

• FDA approval · 2017-11-22
  FDA Approved: BIVALIRUDIN — Original Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare's generic version of bivalirudin, expanding access to the anticoagulant used to prevent clotting during proce…

• FDA approval · 2017-10-31
  FDA Approved: PLAVIX — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for PLAVIX (clopidogrel) submitted by Sanofi-Aventis U.S. LLC. The approval concerns changes to the …

• FDA approval · 2017-10-16
  FDA Approved: PRASUGREL — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s generic prasugrel (Original Application) for use as an antiplatelet therapy to reduce cardiovascular events in p…

• FDA approval · 2017-10-16
  FDA Approved: PRASUGREL — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for a generic prasugrel product from Aurobindo Pharma Limited, enabling market entry as a generic anti…

• FDA approval · 2017-07-12
  FDA Approved: PRASUGREL — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved Mylan Pharmaceuticals' original application for a generic prasugrel product, intended to reduce thrombotic events in adults wit…