Heart Failure

• FDA approval · 2012-08-15
  FDA Approved: METOPROLOL SUCCINATE — Original Application (BluePoint Laboratories)

  FDA approved a generic metoprolol succinate product (BluePoint Laboratories) via an Original Application (ANDA). The product is a generic be…

• FDA approval · 2012-08-13
  FDA Approved: ZESTRIL — Supplemental Application (Upsher-Smith Laboratories, LLC)

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

• FDA approval · 2012-08-13
  FDA Approved: LANOXIN — Supplemental Application (Advanz Pharma (US) Corp.)

  The FDA approved a supplemental application for LANOXIN (digoxin) submitted by Advanz Pharma (US) Corp.

• FDA approval · 2012-08-01
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approved metoprolol succinate as a generic product through an original ANDA submission by Quallent Pharmaceuticals Health LLC.

• FDA approval · 2012-05-11
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for furosemide by Hikma Pharmaceuticals USA Inc., authorizing a generic version of the diuretic. Thi…

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• FDA approval · 2012-05-10
  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 · 2012-05-09
  FDA Approved: FUROSEMIDE — Supplemental Application (Solco Healthcare LLC)

  FDA approved a supplemental application for furosemide from Solco Healthcare LLC, authorizing continued production and marketing of the gene…

• FDA approval · 2012-04-27
  FDA Approved: ATACAND — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' supplemental application for ATACAND (candesartan cilexetil). This action updates the drug's labeling as p…

• FDA approval · 2012-04-27
  FDA Approved: DIGOXIN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Digoxin submitted by Sandoz Inc.

• FDA approval · 2012-03-29
  FDA Approved: ZESTRIL — Supplemental Application (Upsher-Smith Laboratories, LLC)

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

• FDA approval · 2012-03-27
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for LASIX (furosemide) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2012-03-05
  FDA Approved: DOBUTAMINE HYDROCHLORIDE IN DEXTROSE — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for Dobutamine Hydrochloride in Dextrose, a Baxter product, indicating an approved change or additio…

• FDA approval · 2012-01-23
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for carvedilol, a generic beta-blocker, for a new or expanded generic…

• FDA approval · 2011-12-31
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Solco Healthcare U.S., LLC)

  FDA approves Solco Healthcare U.S., LLC's supplemental application for hydrochlorothiazide, enabling continued supply of the generic diureti…

• FDA approval · 2011-12-30
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Digoxin (DIGOXIN) from Hikma Pharmaceuticals USA Inc.

• FDA approval · 2011-12-15
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved METOPROLOL SUCCINATE as a generic via an Original Application (ANDA) for Mylan Pharmaceuticals Inc.

• FDA approval · 2011-12-14
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for the generic fixed-dose combination of spironolactone and hydrochlorothiazide from Sun Pharmaceut…

• FDA approval · 2011-11-28
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for spironolactone filed by Amneal Pharmaceuticals LLC, a generic product. The approval confirms cha…

• FDA approval · 2011-11-18
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Digoxin from Hikma Pharmaceuticals USA Inc., authorizing changes to the product's labeling. …

• FDA approval · 2011-11-14
  FDA Approved: LANOXIN — Supplemental Application (Advanz Pharma (US) Corp.)

  The FDA approved a supplemental application for LANOXIN (digoxin) submitted by Advanz Pharma (US) Corp., corresponding to a labeling update …

• FDA approval · 2011-11-14
  FDA Approved: LANOXIN — Supplemental Application (Covis Pharma US, Inc)

  FDA approved a supplemental application for LANOXIN (digoxin) from Covis Pharma US, Inc., likely resulting in labeling updates for the produ…

• FDA approval · 2011-11-14
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Exelan Pharmaceuticals Inc.)

  FDA approved a supplemental application for hydrochlorothiazide submitted by Exelan Pharmaceuticals Inc.

• FDA approval · 2011-10-17
  FDA Approved: PERINDOPRIL ERBUMINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for PERINDOPRIL ERBUMINE from Aurobindo Pharma Limited (ANDA) to market the generic product.

• FDA approval · 2011-10-13
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for hydrochlorothiazide from Unichem Pharmaceuticals (USA), Inc., approving a generic hydrochlor…

• FDA approval · 2011-09-26
  FDA Approved: DIGOXIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Digoxin from Hikma Pharmaceuticals USA Inc., resulting in updated labeling for the product.