Hypertension

• FDA approval · 2012-01-19
  FDA Approved: LOTENSIN — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for LOTENSIN (benazepril hydrochloride) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2012-01-19
  FDA Approved: MICARDIS HCT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for MICARDIS HCT (telmisartan and hydrochlorothiazide) by Boehringer Ingelheim Pharmaceuticals, Inc.…

• FDA approval · 2012-01-19
  FDA Approved: LOTREL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Lotrel, a combination of amlodipine besylate and benazepril hydrochloride, submitted by Nova…

• FDA approval · 2012-01-19
  FDA Approved: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for benazepril hydrochloride and hydrochlorothiazide (Padagis US LLC), resulting in updated labeling…

• FDA approval · 2012-01-19
  FDA Approved: TRIBENZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Tribenzor, a fixed-dose combination of olmesartan medoxomil, amlodipine besylate, and hydrochlor…

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• FDA approval · 2012-01-19
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Triamterene and Hydrochlorothiazide from BluePoint Laboratories, authorizing changes to the prev…

• FDA approval · 2012-01-19
  FDA Approved: METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's original application for metoprolol tartrate and hydrochlorothiazide as a generic fixed-dose combination p…

• FDA approval · 2012-01-19
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Hydrochlorothiazide (generic) submitted by Teva Pharmaceuticals USA, Inc., under the ANDA progra…

• FDA approval · 2012-01-18
  FDA Approved: EXFORGE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Exforge (amlodipine besylate and valsartan) to update the labeling for this antihypertensive…

• FDA approval · 2012-01-18
  FDA Approved: DIOVAN HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Diovan HCT (valsartan and hydrochlorothiazide) submitted by Novartis Pharmaceuticals Corpora…

• FDA approval · 2012-01-18
  FDA Approved: BENICAR HCT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Benicar HCT (olmesartan medoxomil-hydrochlorothiazide) from Cosette Pharmaceuticals, Inc.

• FDA approval · 2012-01-18
  FDA Approved: AVAPRO — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for AVAPRO (irbesartan) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2012-01-18
  FDA Approved: EXFORGE HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for EXFORGE HCT, a fixed-dose combination of amlodipine, valsartan, and hydrochlorothiazide, sub…

• FDA approval · 2012-01-18
  FDA Approved: AZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for AZOR (amlodipine besylate and olmesartan medoxomil) from Cosette Pharmaceuticals, Inc.

• FDA approval · 2012-01-17
  FDA Approved: ATENOLOL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for atenolol from Aurobindo Pharma Limited, sanctioning a generic Atenolol product. This approva…

• FDA approval · 2012-01-03
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for losartan potassium from Quallent Pharmaceuticals Health LLC for an existing generic product.

• FDA approval · 2011-12-31
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for amlodipine besylate from Aurobindo Pharma Limited, confirming continued approval of this generic…

• FDA approval · 2011-12-31
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for amlodipine besylate from Teva Pharmaceuticals, Inc. Amlodipine besylate is used to treat hyp…

• FDA approval · 2011-12-31
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Supplemental Application (Archis Pharma LLC)

  The FDA approved a supplemental application for nicardipine hydrochloride from Archis Pharma LLC, approving the generic product under the AN…

• 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 · 2011-12-20
  FDA Approved: EDARBYCLOR — Original Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  FDA approved EDARBYCLOR, a fixed-dose combination of azilsartan medoxomil and chlorthalidone, under an original NDA. The approval was grante…

• 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: BYSTOLIC — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental application for BYSTOLIC (nebivolol hydrochloride).

• FDA approval · 2011-12-14
  FDA Approved: EDARBI — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  FDA approved a supplemental application for EDARBI (azilsartan kamedoxomil) submitted by Azurity Pharmaceuticals, Inc. The action approves c…

• 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…