Coronary Syndrome

• FDA approval · 2014-05-29
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Heparin Sodium (Hospira, Inc.), updating the approved generic product under the ANDA program.

• FDA approval · 2014-04-11
  FDA Approved: CLOPIDOGREL — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's original application for clopidogrel, enabling a generic version of the antiplatelet medicatio…

• FDA approval · 2014-03-04
  FDA Approved: CLOPIDOGREL — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s original generic application for clopidogrel bisulfate (clopidogrel).

• FDA approval · 2013-12-12
  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.

• FDA approval · 2013-11-19
  FDA Approved: EFFIENT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

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• FDA approval · 2013-10-30
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2013-10-10
  FDA Approved: AGGRASTAT — Supplemental Application (Medicure International Inc)

  FDA approved a supplemental application for AGGRASTAT (tirofiban) from Medicure International Inc.

• FDA approval · 2013-06-05
  FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for enoxaparin sodium (Lovenox) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2013-05-20
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Hospira's heparin sodium, indicating a modification to the product's approval (likely labeling o…

• FDA approval · 2013-04-04
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Inc)

  The FDA approved a supplemental application for clopidogrel bisulfate submitted by Dr. Reddy's Laboratories Inc, for their generic clopidogr…

• FDA approval · 2013-03-29
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2013-03-05
  FDA Approved: AGGRASTAT — Supplemental Application (Medicure International Inc)

  FDA approved a supplemental application for AGGRASTAT (tirofiban) submitted by Medicure International Inc, indicating an update to the drug'…

• FDA approval · 2012-12-05
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Brilinta (ticagrelor) from AstraZeneca Pharmaceuticals LP. This action approves changes to Brili…

• FDA approval · 2012-11-30
  FDA Approved: EFFIENT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2012-06-06
  FDA Approved: AGGRASTAT — Supplemental Application (Medicure International Inc)

  FDA approved a supplemental application for AGGRASTAT (tirofiban) submitted by Medicure International Inc.

• FDA approval · 2012-06-06
  FDA Approved: AGGRASTAT — Supplemental Application (Medicure International Inc)

  FDA approved a supplemental application for AGGRASTAT (tirofiban) submitted by Medicure International Inc., resulting in labeling updates fo…

• FDA approval · 2012-05-17
  FDA Approved: CLOPIDOGREL BISULFATE — Original Application (Dr.Reddy's Laboratories Inc)

  FDA approved Dr. Reddy's Laboratories' clopidogrel bisulfate as an original application (ANDA), enabling a generic version of the antiplatel…

• FDA approval · 2012-05-17
  FDA Approved: CLOPIDOGREL — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's generic clopidogrel; an antiplatelet agent used to reduce cardiovascular events in patients with acute coronary syndrome…

• FDA approval · 2012-04-18
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approval of a supplemental application for clopidogrel bisulfate submitted by Dr. Reddy's Laboratories Limited.

• FDA approval · 2012-03-23
  FDA Approved: EFFIENT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2011-12-23
  FDA Approved: HEPARIN SODIUM AND DEXTROSE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Heparin Sodium and Dextrose (Hospira, Inc.). The update concerns labeling/indications for this a…

• FDA approval · 2011-09-27
  FDA Approved: EFFIENT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA has approved a supplemental application for EFFIENT (prasugrel hydrochloride) from Cosette Pharmaceuticals, Inc. The action represen…

• FDA approval · 2011-07-20
  FDA Approved: BRILINTA — Original Application (AstraZeneca Pharmaceuticals LP)

  FDA approved Brilinta (ticagrelor) through an original application for use in patients with acute coronary syndrome to reduce the risk of ca…

• FDA approval · 2010-12-06
  FDA Approved: EFFIENT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved Cosette Pharmaceuticals' supplemental application for EFFIENT (prasugrel hydrochloride).

• FDA approval · 2010-07-23
  FDA Approved: ENOXAPARIN SODIUM — Original Application (Sandoz Inc)

  FDA approved Sandoz Inc's Original Application for Enoxaparin Sodium, a generic injectable anticoagulant. The approval authorizes marketing …