Hypertension

• FDA approval · 2014-07-07
  FDA Approved: TELMISARTAN — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved Mylan Pharmaceuticals' original ANDA for a generic telmisartan product. The approval makes a generic version of telmisartan ava…

• FDA approval · 2014-07-07
  FDA Approved: TELMISARTAN — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's original application for a generic telmisartan product.

• FDA approval · 2014-07-02
  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. This …

• FDA approval · 2014-06-27
  FDA Approved: BENICAR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA granted a supplemental approval for Benicar (olmesartan medoxomil) submitted by Cosette Pharmaceuticals, Inc.

• FDA approval · 2014-06-27
  FDA Approved: TRIBENZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Tribenzor (olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide) submitted by Cosett…

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• FDA approval · 2014-06-27
  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 · 2014-06-26
  FDA Approved: VALSARTAN — Original Application (Ohm Laboratories Inc.)

  FDA approved Ohm Laboratories Inc.'s valsartan under an Original Abbreviated New Drug Application (ANDA), establishing a generic version of …

• FDA approval · 2014-06-20
  FDA Approved: TRIBENZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for TRIBENZOR, a fixed-dose combination of olmesartan medoxomil, amlodipine besylate, and hydroc…

• FDA approval · 2014-06-13
  FDA Approved: LISINOPRIL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA granted a supplemental approval for lisinopril under ANDA077622 for Aurobindo Pharma Limited.

• FDA approval · 2014-06-13
  FDA Approved: AZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for AZOR (amlodipine besylate and olmesartan medoxomil) submitted by Cosette Pharmaceuticals, In…

• FDA approval · 2014-06-13
  FDA Approved: BENICAR HCT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Benicar HCT, combining olmesartan medoxomil with hydrochlorothiazide, for hypertension; appr…

• FDA approval · 2014-06-13
  FDA Approved: TRIBENZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA granted a supplemental approval for Tribenzor (olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide) submitted by Cosette Ph…

• FDA approval · 2014-06-13
  FDA Approved: BENICAR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2014-06-12
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for the fixed-dose combination of bisoprolol fumarate and hydrochlorothiazide. This combination …

• FDA approval · 2014-06-11
  FDA Approved: DOXAZOSIN — Original Application (Accord Healthcare Inc.)

  FDA approval of Accord Healthcare Inc.'s original application for generic doxazosin (DOXAZOSIN), an alpha-1 blocker indicated for hypertensi…

• FDA approval · 2014-06-09
  FDA Approved: EXFORGE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Exforge (amlodipine besylate and valsartan) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2014-06-09
  FDA Approved: EXFORGE HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for EXFORGE HCT (amlodipine valsartan and hydrochlorothiazide) from Novartis Pharmaceuticals Corpora…

• FDA approval · 2014-06-05
  FDA Approved: PROCARDIA XL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Procardia XL (nifedipine) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2014-05-30
  FDA Approved: DIOVAN HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approves a supplemental application for Diovan HCT (valsartan/hydrochlorothiazide) submitted by Novartis Pharmaceuticals Corporation. Th…

• FDA approval · 2014-05-28
  FDA Approved: AVALIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)

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

• FDA approval · 2014-05-22
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for a fixed-dose combination of amlodipine and atorvastatin (amlodipine besylate and atorvastatin ca…

• FDA approval · 2014-05-14
  FDA Approved: AZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2014-05-09
  FDA Tentative Approval: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Solco Healthcare US, LLC)

  FDA issued tentative approval for a generic fixed-dose combination of irbesartan and hydrochlorothiazide (Solco Healthcare US, LLC) under Or…

• FDA approval · 2014-05-07
  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 · 2014-05-06
  FDA Approved: CLONIDINE TRANSDERMAL SYSTEM — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma's clonidine transdermal system through an Original Application (ANDA 090873), marking the first approval of a ge…