Heart Failure

• FDA approval · 2015-09-01
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Amici Pharma, Inc)

  FDA approved a supplemental application for enalapril maleate from Amici Pharma, Inc.

• FDA approval · 2015-08-31
  FDA Approved: RAMIPRIL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for ramipril (generic ACE inhibitor) under the ANDA, enabling a revised/exp…

• 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: ENALAPRIL MALEATE — Supplemental Application (OCEANSIDE PHARMACEUTICALS)

  The FDA approved a supplemental application for enalapril maleate submitted by Oceanside Pharmaceuticals, marking an approved labeling actio…

• 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.

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• FDA approval · 2015-08-17
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Northstar RxLLC)

  FDA approves Northstar RxLLC's supplemental application for enalapril maleate, confirming the approval of this generic ACE inhibitor.

• FDA approval · 2015-08-17
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for enalapril maleate filed by Northstar RxLLC.

• FDA approval · 2015-08-07
  FDA Approved: FUROSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for furosemide submitted by Chartwell RX, LLC.

• CLINICAL_TRIALS approval · 2015-07-30
  Clinical Trial Update: SynCardia Freedom Driver System Study

  The SynCardia Freedom Driver System has been approved for marketing to support patients with heart failure. This approval includes patients …

• FDA approval · 2015-07-29
  FDA Approved: ETHACRYNATE SODIUM — Original Application (Par Health USA, LLC)

  FDA approved Ethacrynate Sodium as an original ANDA for Par Health USA, LLC.

• FDA approval · 2015-07-28
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Digoxin from Hikma Pharmaceuticals USA Inc. for continued marketing of the drug and potential la…

• FDA approval · 2015-07-28
  FDA Approved: LANOXIN — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approves a supplemental application for LANOXIN (digoxin) from Advanz Pharma (US) Corp., under the supplemental NDA framework.

• FDA approval · 2015-07-22
  FDA Approved: LOTENSIN — Supplemental Application (Validus Pharmaceuticals LLC)

  The FDA approved a supplemental NDA for Lotensin (benazepril hydrochloride) filed by Validus Pharmaceuticals LLC.

• FDA approval · 2015-07-21
  FDA Approved: TRANDOLAPRIL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for Trandolapril (generic) under the ANDA program. This confirms regulatory cle…

• FDA approval · 2015-06-26
  FDA Approved: JARDIANCE — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Jardiance (empagliflozin) by Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA approval · 2015-06-09
  FDA Approved: VALSARTAN — Original Application (Solco Healthcare US, LLC)

  FDA approved the original ANDA for valsartan (generic) submitted by Solco Healthcare US, LLC, authorizing marketing of this ARB for hyperten…

• FDA approval · 2015-06-05
  FDA Approved: FUROSEMIDE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  FDA approved a supplemental NDA for furosemide from Marlex Pharmaceuticals, Inc., updating the product label.

• FDA approval · 2015-05-01
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for enalapril maleate from ScieGen Pharmaceuticals, indicating continued/expanded authorization …

• FDA approval · 2015-04-26
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Spironolactone from Mylan Pharmaceuticals Inc., indicating an approved change to an already-appr…

• FDA approval · 2015-04-24
  FDA Approved: TRANDOLAPRIL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a generic Trandolapril product from Aurobindo Pharma Limited.

• FDA approval · 2015-04-15
  FDA Approved: CORLANOR — Original Application (Amgen Inc)

  FDA approves CORLANOR (ivabradine) from Amgen in its original NDA for chronic heart failure with reduced ejection fraction in adults. In add…

• FDA approval · 2015-04-09
  FDA Approved: LISINOPRIL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approves a supplemental application for lisinopril filed by Quallent Pharmaceuticals Health LLC under ANDA 077321, enabling continued ma…

• FDA approval · 2015-04-06
  FDA Approved: DIGOXIN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for Digoxin, submitted by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2015-04-02
  FDA Approved: BIDIL — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for BIDIL (hydralazine hydrochloride and isosorbide dinitrate) submitted by Azurity Pharmaceutic…

• FDA approval · 2015-03-31
  FDA Approved: LOSARTAN POTASSIUM TABLETS, 25 MG — Supplemental Application (Jubilant Cadista Pharmaceuticals Inc.)

  FDA approved a supplemental application to add a 25 mg strength of Losartan Potassium Tablets, expanding the product's dosage options. The a…