Coronary Syndrome

• FDA approval · 2017-07-10
  FDA Approved: PLAVIX — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Plavix (clopidogrel) by Sanofi-Aventis U.S. LLC, resulting in changes to the product labeling.

• FDA approval · 2016-08-11
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2016-07-22
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2016-07-12
  FDA Approved: EFFIENT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA has approved a supplemental application for Effient (prasugrel hydrochloride) submitted by Cosette Pharmaceuticals, Inc. This action…

• FDA approval · 2016-06-16
  FDA Approved: AGGRASTAT — Supplemental Application (Medicure International Inc)

  FDA approved a supplemental application for AGGRASTAT (tirofiban) submitted by Medicure International Inc. The action updates the drug's lab…

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• FDA approval · 2016-05-11
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Inc)

  The FDA approved a supplemental application filed by Dr. Reddy's Laboratories Inc for clopidogrel bisulfate (generic) to support changes to …

• FDA approval · 2016-05-11
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for CLOPIDOGREL BISULFATE submitted by Dr. Reddy's Laboratories Limited.

• FDA approval · 2016-05-10
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (RADHA PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for clopidogrel bisulfate (generic clopidogrel) from Radha Pharmaceuticals, Inc., indicating approva…

• FDA approval · 2016-03-21
  FDA Approved: BIVALIRUDIN — Supplemental Application (Civica, Inc.)

  FDA approved a Civica, Inc.-submitted supplemental application for Bivalirudin, updating its regulatory status for use as an anticoagulant. …

• FDA approval · 2016-03-02
  FDA Approved: KENGREAL — Supplemental Application (Chiesi USA, Inc.)

  FDA approved a supplemental application for KENGREAL (cangrelor) from Chiesi USA, Inc., resulting in an updated labeling for the product.

• FDA approval · 2015-12-08
  FDA Approved: EPTIFIBATIDE — Original Application (Eugia US LLC)

  FDA approved Eugia US LLC's original ANDA for Eptifibatide, a GP IIb/IIIa inhibitor used to prevent clot formation in patients with acute co…

• FDA approval · 2015-11-13
  FDA Approved: HEPARIN SODIUM — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Heparin Sodium submitted by Fresenius Kabi USA, LLC (NDA 017651). The approval updates labeling …

• FDA approval · 2015-08-24
  FDA Approved: ENOXAPARIN SODIUM — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for ENOXAPARIN SODIUM submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2015-07-28
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Inc)

  FDA approved a supplemental application for clopidogrel bisulfate from Dr. Reddy's Laboratories Inc, for a generic version of clopidogrel.

• FDA approval · 2015-07-16
  FDA Approved: PLAVIX — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA lists a supplemental application for Plavix (clopidogrel) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2015-07-07
  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 · 2015-06-24
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approves a supplemental application for Brilinta (ticagrelor) from AstraZeneca. The approval updates Brilinta's labeling as described in…

• FDA approval · 2015-04-21
  FDA Approved: AGGRASTAT — Supplemental Application (Medicure International Inc)

  FDA approved a supplemental NDA for AGGRASTAT (tirofiban) from Medicure International Inc. The approval pertains to changes to the product's…

• FDA approval · 2015-03-26
  FDA Approved: BRILINTA — Supplemental Application (AstraZeneca Pharmaceuticals LP)

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

• FDA approval · 2014-10-16
  FDA Approved: ARGATROBAN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental NDA for Argatroban from Hikma Pharmaceuticals USA Inc., granting additional authorization under a supplemental a…

• FDA approval · 2014-09-15
  FDA Approved: CLOPIDOGREL BISULFATE — Original Application (RADHA PHARMACEUTICALS, INC.)

  FDA approved the original ANDA for clopidogrel bisulfate, a generic antiplatelet agent, expanding access to a therapy that reduces vascular …

• FDA approval · 2014-06-23
  FDA Approved: ENOXAPARIN SODIUM — Original Application (Italfarmaco SpA)

  FDA approved the original application for ENOXAPARIN SODIUM (enoxaparin sodium) submitted by Italfarmaco SpA under an ANDA. The approval con…

• FDA approval · 2014-06-12
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for clopidogrel bisulfate from Dr. Reddy's Laboratories Limited. This action confirms approval of th…

• FDA approval · 2014-06-12
  FDA Approved: HEPARIN SODIUM — Original Application (Sandoz Inc.)

  FDA approved Sandoz Inc.'s original application for generic heparin sodium, an injectable anticoagulant used to prevent and treat thrombotic…

• FDA approval · 2014-06-11
  FDA Approved: CLOPIDOGREL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application to authorize a generic clopidogrel bisulfate product from Aurobindo Pharma Limited.