Hypertension

• FDA approval · 2013-05-03
  FDA Approved: CANDESARTAN CILEXETIL — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original application for candesartan cilexetil (generic) by Mylan Pharmaceuticals Inc., authorizing the marketing of a gene…

• FDA approval · 2013-05-02
  FDA Approved: CARDENE IV — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved Baxter's supplemental NDA for Cardene IV (nicardipine hydrochloride), authorizing changes to the approved intravenous product u…

• FDA approval · 2013-05-02
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva Pharmaceuticals' supplemental application for amlodipine besylate under ANDA 076846.

• FDA approval · 2013-04-29
  FDA Approved: METOPROLOL — Original Application (Baxter Healthcare Corporation)

  FDA approved Baxter's generic metoprolol tartrate (METOPROLOL TARTRATE) as an Original Application. The approval supports the generic produc…

• FDA approval · 2013-04-29
  FDA Approved: QUINAPRIL — Original Application (Aurobindo Pharma Limited)

  FDA approves the original generic application for quinapril hydrochloride (quinapril HCl) from Aurobindo Pharma Limited.

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• FDA approval · 2013-04-26
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Hydralazine hydrochloride from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2013-04-26
  FDA Approved: CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for ANI Pharmaceuticals' generic candesartan cilexetil and hydrochlorothiazide.

• FDA approval · 2013-04-26
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Supplemental Application (American Regent, Inc.)

  The FDA approved a supplemental application for Hydralazine Hydrochloride from American Regent, Inc.

• FDA approval · 2013-04-25
  FDA Approved: NIFEDIPINE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a generic nifedipine product from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. under ANDA 202644.

• FDA approval · 2013-04-19
  FDA Approved: VALSARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approves the original application for valsartan and hydrochlorothiazide from Macleods Pharmaceuticals Limited for treating hypertension.

• FDA approval · 2013-03-28
  FDA Approved: AMLODIPINE AND VALSARTAN — Original Application (Strides Pharma Science Limited)

  The FDA approved Strides Pharma Science Limited's original application for a generic fixed-dose combination of amlodipine and valsartan for …

• FDA approval · 2013-03-27
  FDA Approved: HYZAAR — Supplemental Application (Organon LLC)

  FDA approves a supplemental application for HYZAAR (losartan potassium and hydrochlorothiazide) submitted by Organon LLC.

• FDA approval · 2013-03-21
  FDA Approved: VALSARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved the original application for a generic fixed-dose combination of valsartan and hydrochlorothiazide manufactured by Alembic Phar…

• FDA approval · 2013-03-21
  FDA Approved: VALSARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals’ original-application generic fixed-dose combination of valsartan and hydrochlorothiazide for hypertensio…

• FDA approval · 2013-03-21
  FDA Approved: VALSARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's valsartan and hydrochlorothiazide as a generic combination tablet for treating hypertension under an…

• FDA approval · 2013-03-19
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Losartan Potassium and Hydrochlorothiazide from Teva Pharmaceuticals USA, Inc., under an AND…

• FDA approval · 2013-03-18
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for metoprolol tartrate from Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2013-03-14
  FDA Approved: LOPRESSOR — Supplemental Application (Validus Pharmaceuticals LLC)

  The FDA approved a supplemental application for Lopressor (metoprolol tartrate) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2013-03-14
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for the combination drug Losartan Potassium and Hydrochlorothiazide from Alembic Pharmaceuticals Lim…

• FDA approval · 2013-03-12
  FDA Approved: DURACLON — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for DURACLON (clonidine hydrochloride) from Mylan Institutional LLC.

• FDA approval · 2013-03-11
  FDA Approved: IRBESARTAN — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for IRBESARTAN submitted by NorthStar RxLLC under an ANDA. The approval pertains to the supplemental…

• FDA approval · 2013-03-05
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Losartan Potassium and Hydrochlorothiazide from Lupin Pharmaceuticals, expanding its approva…

• FDA approval · 2013-02-28
  FDA Approved: AVAPRO — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a Supplemental Application for AVAPRO (irbesartan) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2013-02-27
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for metoprolol tartrate from Hospira, Inc., indicating an updated regulatory action on the generic p…

• FDA approval · 2013-02-22
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original application for a generic fixed-dose combination of irbesartan and hydrochlorothiazide …