Hypertension

• FDA approval · 2017-09-19
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved Unichem Pharmaceuticals' original ANDA for a generic fixed-dose combination tablet of irbesartan and hydrochlorothiazide. I…

• FDA approval · 2017-08-23
  FDA Approved: CANDESARTAN CILEXETIL — Original Application (Zydus Lifesciences Limited)

  FDA approved the Original Application for candesartan cilexetil by Zydus Lifesciences Limited, confirming a generic version of the antihyper…

• FDA approval · 2017-08-14
  FDA Approved: AMLODIPINE AND OLMESARTAN MEDOXOMIL — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' original application for a fixed-dose combination of amlodipine and olmesartan medoxomil for treating …

• FDA approval · 2017-08-11
  FDA Approved: TIADYLT ER — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approves TIADYLT ER (diltiazem hydrochloride extended-release) from Zydus Pharmaceuticals (USA) Inc. under an original ANDA, providing a…

• FDA approval · 2017-08-08
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved Zydus Pharmaceuticals USA's original application for diltiazem hydrochloride as a generic product, enabling its use for the man…

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• FDA approval · 2017-08-03
  FDA Approved: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Padagis US LLC)

  The FDA approved a supplemental application for Benazepril hydrochloride and hydrochlorothiazide, submitted by Padagis US LLC.

• FDA approval · 2017-07-28
  FDA Approved: NADOLOL — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved Nadolol as a generic drug in an Original Application (ANDA) for Zydus Pharmaceuticals USA Inc.

• FDA approval · 2017-07-25
  FDA Approved: TELMISARTAN — Original Application (Modavar Pharmaceuticals LLC)

  The FDA approved Modavar Pharmaceuticals LLC's original application for telmisartan, enabling a generic version of the antihypertensive drug…

• FDA approval · 2017-07-21
  FDA Approved: ZESTRIL — Supplemental Application (Upsher-Smith Laboratories, LLC)

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

• FDA approval · 2017-07-21
  FDA Approved: LOTREL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Lotrel (amlodipine besylate and benazepril hydrochloride) submitted by Novartis Pharmaceutic…

• FDA approval · 2017-07-21
  FDA Approved: VASERETIC — Supplemental Application (Bausch Health US, LLC)

  The FDA approved a supplemental application for VASERETIC (enalapril maleate and hydrochlorothiazide) filed by Bausch Health US, LLC.

• FDA approval · 2017-07-21
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a generic fixed-dose combination tablet of losartan potassium and hydrochlorothiazide from Unichem Pharmaceuticals (USA), I…

• FDA approval · 2017-07-19
  FDA Approved: CANDESARTAN — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for candesartan from Macleods Pharmaceuticals Limited, enabling a generic version of the drug.

• FDA approval · 2017-07-17
  FDA Approved: AMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMIL — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' original application for a fixed-dose combination generic of amlodipine besylate and olmesartan medoxo…

• FDA approval · 2017-07-14
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for furosemide submitted by Hikma Pharmaceuticals USA Inc. The notice confirms regulatory approval o…

• FDA approval · 2017-07-13
  FDA Approved: EPLERENONE — Original Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare's original (ANDA) application for the generic drug eplerenone (Eplerenone). The product is intended for indic…

• FDA approval · 2017-07-10
  FDA Approved: AVALIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for Avalide (irbesartan and hydrochlorothiazide) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2017-07-07
  FDA Approved: DOXAZOSIN — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for generic doxazosin from Zydus Lifesciences Limited. This product provides a generic option for the …

• FDA approval · 2017-07-05
  FDA Approved: AMLODIPINE AND OLMESARTAN MEDOXOMIL — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approves the original application for a generic fixed-dose combination of amlodipine and olmesartan medoxomil from Glenmark for the trea…

• FDA approval · 2017-06-23
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application from Prasco Laboratories for the combination drug amlodipine and atorvastatin. The product is intend…

• FDA approval · 2017-06-20
  FDA Approved: CANDESARTAN CILEXETIL — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' original application for candesartan cilexetil, enabling the marketing of a generic candesartan cilexe…

• FDA approval · 2017-06-13
  FDA Approved: NISOLDIPINE — Supplemental Application (Prasco Laboratories)

  FDA approves a supplemental application for Nisoldipine submitted by Prasco Laboratories.

• FDA approval · 2017-06-08
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a generic fixed-dose combination of irbesartan and hydrochlorothiazide from Hikma Pharmaceuticals USA Inc. through an Original …

• FDA approval · 2017-06-08
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical's diltiazem hydrochloride as a generic product under an original ANDA.

• FDA approval · 2017-06-02
  FDA Approved: NADOLOL — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal's original application for a generic nadolol, a non-selective beta-blocker used to treat hypertension and to prevent…