Myocardial Infarction

• FDA approval · 2016-03-21
  FDA Approved: LOPRESSOR — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for Lopressor (metoprolol tartrate) filed by Validus Pharmaceuticals LLC.

• 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 · 2016-02-25
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  The FDA approved a supplemental application for enalapril maleate from Taro Pharmaceuticals U.S.A., Inc., confirming approval of a generic e…

• FDA approval · 2016-02-24
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  The FDA approved a supplemental application for lisinopril from Solco Healthcare U.S., LLC.

• FDA approval · 2016-02-23
  FDA Approved: CAPTOPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for CAPTOPRIL from Hikma Pharmaceuticals USA Inc.

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• FDA approval · 2016-02-18
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for enalapril maleate from Northstar RxLLC. The approval confirms changes associated with this gener…

• FDA approval · 2016-02-18
  FDA Approved: QUINAPRIL — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for Quinapril submitted by BluePoint Laboratories. The action updates the drug’s labeling.

• FDA approval · 2016-02-18
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for Enalapril Maleate from Northstar RxLLC under an ANDA.

• FDA approval · 2016-02-16
  FDA Approved: CAPTOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' supplemental application for CAPTOPRIL (captopril) under an existing ANDA. The action confirms continue…

• FDA approval · 2016-02-02
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  The FDA approved a supplemental application for lisinopril from Solco Healthcare U.S., LLC.

• FDA approval · 2016-01-11
  FDA Approved: VALSARTAN — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal Pharmaceuticals LLC's Original Application for VALSARTAN, authorizing the marketing of a generic valsartan product.

• FDA approval · 2016-01-04
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  FDA approved a supplemental application for lisinopril from Solco Healthcare U.S., LLC, supporting continued availability of the generic ACE…

• FDA approval · 2015-12-17
  FDA Approved: VALSARTAN — Supplemental Application (Ohm Laboratories Inc.)

  FDA approved a supplemental application for VALSARTAN from Ohm Laboratories Inc. (ANDA077492).

• FDA approval · 2015-12-11
  FDA Approved: VALSARTAN — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for VALSARTAN submitted by Alembic Pharmaceuticals Limited.

• 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 · 2015-11-25
  FDA Approved: QUINAPRIL — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for Quinapril by Cipla USA Inc., indicating an approval of an additional Quinapril product or labeli…

• FDA approval · 2015-11-24
  FDA Approved: QUINAPRIL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Quinapril hydrochloride from Aurobindo Pharma Limited, enabling the generic product Quinapril hy…

• FDA approval · 2015-11-20
  FDA Approved: VALSARTAN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for valsartan submitted by Lupin Pharmaceuticals, Inc.

• 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 · 2015-11-09
  FDA Approved: VALSARTAN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for valsartan from Aurobindo Pharma Limited, allowing changes to the approved generic product.

• FDA approval · 2015-10-30
  FDA Approved: VALSARTAN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for VALSARTAN by Mylan Pharmaceuticals Inc.

• FDA approval · 2015-09-10
  FDA Approved: TENORMIN — Supplemental Application (Almatica Pharma LLC)

  The FDA approved a supplemental application for TENORMIN (atenolol) submitted by Almatica Pharma LLC.

• FDA approval · 2015-09-08
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Metoprolol Tartrate from Aurobindo Pharma Limited, a generic beta-blocker used in cardiovascular…

• FDA approval · 2015-08-25
  FDA Approved: ZESTRIL — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved Upsher-Smith Laboratories' supplemental application for ZESTRIL (lisinopril), resulting in approved labeling changes. Lisin…

• FDA approval · 2015-08-25
  FDA Approved: LISINOPRIL — Supplemental Application (Aurobindo Pharma Limited)

  FDA granted supplemental approval for lisinopril from Aurobindo Pharma Limited under the ANDA program.