Heart Failure

• FDA approval · 2010-01-28
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved a supplemental application for enalapril maleate from Taro Pharmaceuticals U.S.A., Inc., authorizing the generic product under …

• FDA approval · 2010-01-21
  FDA Approved: BUMEX — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for Bumex (bumetanide) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2010-01-21
  FDA Approved: MILRINONE LACTATE IN DEXTROSE — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Hikma Pharmaceuticals USA Inc.'s Milrinone Lactate in Dextrose as an Original Application (ANDA 090038), establishing a gen…

• FDA approval · 2010-01-19
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  FDA approved a supplemental application for TOPROL XL (metoprolol succinate) submitted by Melinta Therapeutics, LLC.

• FDA approval · 2009-12-22
  FDA Approved: CARVEDILOL — Original Application (Advagen Pharma Limited)

  FDA approves the original application for a generic carvedilol product by Advagen Pharma Limited.

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• FDA approval · 2009-11-18
  FDA Approved: LISINOPRIL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for lisinopril from Quallent Pharmaceuticals Health LLC, approving this generic lisinopril product.

• FDA approval · 2009-10-30
  FDA Approved: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  The FDA approved a supplemental application for Enalapril maleate and hydrochlorothiazide from Taro Pharmaceuticals U.S.A., Inc. to update t…

• FDA approval · 2009-10-29
  FDA Approved: RAMIPRIL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA granted supplemental approval for Lupin Pharmaceuticals’ ramipril generic under the ANDA, authorizing continued marketing of the product…

• FDA approval · 2009-10-22
  FDA Approved: RAMIPRIL — Supplemental Application (Chartwell RX, LLC.)

  FDA approved a supplemental application for RAMIPRIL submitted by Chartwell RX, LLC., indicating approval of a supplemental filing related t…

• FDA approval · 2009-10-22
  FDA Approved: RAMIPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for ramipril submitted by Hikma Pharmaceuticals USA Inc. The action confirms continued approval …

• FDA approval · 2009-10-16
  FDA Approved: CHLOROTHIAZIDE — Original Application (Fresenius Kabi USA, LLC)

  FDA approves Fresenius Kabi USA, LLC's original abbreviated new drug application for chlorothiazide sodium, a thiazide diuretic. The product…

• FDA approval · 2009-08-18
  FDA Approved: BISOPROLOL FUMARATE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a generic version of bisoprolol fumarate from Unichem Pharmaceuticals (USA), Inc. under an Original Application. It is indicate…

• FDA approval · 2009-07-20
  FDA Approved: DIGOXIN — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved the Amneal Pharmaceuticals of New York LLC original application for digoxin (generic digoxin). This approves a generic version …

• FDA approval · 2009-07-09
  FDA Approved: FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE — Original Application (CIPLA USA INC.)

  FDA approved an original application for Fosinopril sodium and hydrochlorothiazide, a fixed-dose combination of an ACE inhibitor with a thia…

• FDA approval · 2009-05-29
  FDA Approved: LISINOPRIL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for lisinopril from Quallent Pharmaceuticals Health LLC, enabling continued access to lisinopril…

• FDA approval · 2009-05-19
  FDA Approved: SAMSCA — Original Application (Otsuka America Pharmaceutical, Inc.)

  FDA approved Samsca (tolvaptan) from Otsuka America for the treatment of clinically significant hyponatremia in adults, including hyponatrem…

• FDA approval · 2009-05-04
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for furosemide from Hikma Pharmaceuticals USA Inc., updating the labeling on an existing product.

• FDA approval · 2009-05-04
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for furosemide submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2009-05-04
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for furosemide submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2009-04-30
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries, Inc.'s supplemental ANDA for spironolactone, granting approval of their generic product for the …

• FDA approval · 2009-03-12
  FDA Approved: FUROSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for furosemide submitted by Chartwell RX, LLC, resulting in updated labeling for the product.

• FDA approval · 2009-02-25
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Spironolactone submitted by Mylan Pharmaceuticals Inc.

• FDA approval · 2009-02-20
  FDA Approved: FUROSEMIDE — Supplemental Application (Solco Healthcare LLC)

  The FDA approved a supplemental application for furosemide from Solco Healthcare LLC, adding a new manufacturing source for the product.

• FDA approval · 2009-02-06
  FDA Approved: FUROSEMIDE — Supplemental Application (Chartwell RX, LLC)

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

• FDA approval · 2009-01-30
  FDA Approved: AMILORIDE HYDROCHLORIDE — Original Application (Sigmapharm Laboratories, LLC)

  FDA approves Sigmapharm Laboratories, LLC's amiloride hydrochloride as an original generic application (ANDA) product space.