Myocardial Infarction

• FDA approval · 2018-04-09
  FDA Approved: VALSARTAN — Original Application (SQUARE PHARMACEUTICALS LIMITED)

  The FDA approved Square Pharmaceuticals Limited's original application for valsartan (generic valsartan).

• 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 · 2018-03-07
  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 · 2018-02-28
  FDA Approved: TNKASE — Supplemental Application (Genentech, Inc.)

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

• 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.…

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• 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 (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 · 2017-07-21
  FDA Approved: ZESTRIL — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for ZESTRIL (lisinopril) submitted by Upsher-Smith Laboratories.

• 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 · 2016-11-30
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (TRUPHARMA LLC)

  FDA approved a supplemental application for metoprolol tartrate submitted by TRUPHARMA LLC. This action approves the supplemental filing for…

• FDA approval · 2016-09-16
  FDA Approved: VALSARTAN — Original Application (Macleods Pharmaceuticals Limited)

  The FDA approved the original ANDA for valsartan from Macleods Pharmaceuticals Limited, making a generic ARB option available. This approval…

• FDA approval · 2016-09-13
  FDA Approved: LISINOPRIL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for lisinopril submitted by Aurobindo Pharma Limited under ANDA 077622.

• FDA approval · 2016-09-08
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  The FDA approved a supplemental application for lisinopril from Solco Healthcare U.S., LLC under an ANDA, confirming the approval of this ge…

• 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 · 2016-07-29
  FDA Approved: QBRELIS — Original Application (Azurity Pharmaceuticals, Inc.)

  The FDA approved QBRELIS (lisinopril) through an original NDA from Azurity Pharmaceuticals. It is indicated for hypertension, heart failure,…

• 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 · 2016-07-13
  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 (Avet) under ANDA 076102 to authorize the generic produ…

• 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…

• 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 · 2016-04-26
  FDA Approved: CARVEDILOL — Supplemental Application (Advagen Pharma Ltd)

  FDA approved a supplemental application for carvedilol filed by Advagen Pharma Ltd, resulting in an additional authorization for the product…

• FDA approval · 2016-04-12
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for enalapril maleate from ScieGen Pharmaceuticals, Inc. (ANDA 075178).