Myocardial Infarction

• FDA approval · 2019-09-13
  FDA Approved: VALSARTAN — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for valsartan from Alembic Pharmaceuticals Limited (ANDA 091367).

• FDA approval · 2019-09-12
  FDA Approved: CLOPIDOGREL — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for clopidogrel from Amneal Pharmaceuticals LLC under ANDA 203751, confirming changes to the approve…

• FDA approval · 2019-09-03
  FDA Approved: VALSARTAN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for valsartan, a generic angiotensin II receptor blocker, for approved labeling…

• FDA approval · 2019-08-20
  FDA Approved: VALSARTAN — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for VALSARTAN submitted by Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2019-08-07
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Inc)

  The FDA approved a supplemental application for clopidogrel bisulfate from Dr. Reddy's Laboratories Inc, indicating a supplemental approval …

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• FDA approval · 2019-08-07
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approves a supplemental application for enalapril maleate by Taro Pharmaceuticals U.S.A., Inc., pertaining to an approved product (gener…

• FDA approval · 2019-08-02
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories' supplemental application for clopidogrel bisulfate, approving changes to the product's labeling.

• FDA approval · 2019-08-02
  FDA Approved: CLOPIDOGREL BISULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for clopidogrel bisulfate by Sun Pharmaceutical Industries, Inc. The approval covers the generic…

• FDA approval · 2019-06-12
  FDA Approved: DIOVAN — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for DIOVAN (valsartan) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2019-05-28
  FDA Approved: HEPARIN SODIUM — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals Inc.'s Heparin Sodium as an Original Application (ANDA 211007), making a generic injectable anticoagul…

• FDA approval · 2019-05-16
  FDA Approved: AGGRASTAT — Supplemental Application (Medicure International Inc)

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

• FDA approval · 2019-05-03
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (TRUPHARMA LLC)

  FDA approved a supplemental application for metoprolol tartrate submitted by TRUPHARMA LLC.

• 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 · 2019-03-12
  FDA Approved: VALSARTAN — Original Application (Ascend Laboratories, LLC)

  FDA approved the original application for valsartan from Ascend Laboratories, making a generic ARB available. It covers indications includin…

• FDA approval · 2019-03-06
  FDA Approved: CARVEDILOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark Pharmaceuticals Inc., USA's supplemental application for carvedilol (generic). The action confirms regulatory approval…

• 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 · 2018-12-20
  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 · 2018-09-14
  FDA Approved: EPLERENONE — Original Application (Breckenridge Pharmaceutical, Inc.)

  FDA approved Breckenridge Pharmaceutical's original ANDA for eplerenone (generic), a mineralocorticoid receptor antagonist used to treat hea…

• 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 · 2018-06-01
  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 · 2018-05-04
  FDA Approved: VALSARTAN — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approves the original (generic) application for valsartan from Unichem Pharmaceuticals (USA), Inc., making a generic valsartan product a…