Hypertension

• FDA approval · 2015-11-13
  FDA Approved: TELMISARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for the Telmisartan and Hydrochlorothiazide product from Lupin Pharmaceuticals, Inc., to support its…

• FDA approval · 2015-11-13
  FDA Approved: DIOVAN HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Diovan HCT (valsartan and hydrochlorothiazide) by Novartis Pharmaceuticals Corporation. The supp…

• FDA approval · 2015-11-12
  FDA Approved: BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for benazepril hydrochloride from Aurobindo Pharma Limited.

• FDA approval · 2015-11-09
  FDA Approved: VALSARTAN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for valsartan from Aurobindo Pharma Limited, allowing changes to the approved generic product.

• FDA approval · 2015-10-30
  FDA Approved: VALSARTAN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for VALSARTAN by Mylan Pharmaceuticals Inc.

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• FDA approval · 2015-10-30
  FDA Approved: TRANDOLAPRIL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Trandolapril from Aurobindo Pharma Limited, authorizing the marketing of a generic product.

• FDA approval · 2015-10-30
  FDA Approved: TELMISARTAN — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories' original ANDA for Telmisartan, enabling a generic version of the antihypertensive drug.

• FDA approval · 2015-10-28
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (ACI Healthcare USA, Inc.)

  The FDA approved a supplemental application for amlodipine besylate from ACI Healthcare USA, Inc., effectively granting regulatory approval …

• FDA approval · 2015-10-28
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for a fixed-dose combination of losartan potassium and hydrochlorothiazide.

• FDA approval · 2015-10-27
  FDA Approved: VALSARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for the valsartan and hydrochlorothiazide combination from Macleods Pharmaceuticals Limited.

• FDA approval · 2015-10-26
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for verapamil hydrochloride (Actavis Pharma, Inc.), a generic product.

• FDA approval · 2015-10-26
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for losartan potassium from Alembic Pharmaceuticals Limited under the ANDA.

• FDA approval · 2015-10-19
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Epic Pharma, LLC)

  The FDA approved Epic Pharma, LLC's supplemental application for amlodipine besylate, enabling a generic version of amlodipine besylate to b…

• FDA approval · 2015-10-19
  FDA Approved: TELMISARTAN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for telmisartan from Mylan Pharmaceuticals, authorizing the generic telmisartan product's continued …

• FDA approval · 2015-10-15
  FDA Approved: IRBESARTAN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for IRBESARTAN (irbesartan), indicating an approved change to the generic p…

• FDA approval · 2015-10-14
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (AiPing Pharmaceutical, Inc.)

  FDA approved AiPing Pharmaceutical's supplemental application for losartan potassium.

• FDA approval · 2015-10-14
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Verapamil Hydrochloride (generic) from Chartwell RX, LLC.

• FDA approval · 2015-10-14
  FDA Approved: LOSARTAN POTASSIUM — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved the original application for a generic losartan potassium tablet by Unichem Pharmaceuticals (USA), Inc. for hypertension and re…

• FDA approval · 2015-10-08
  FDA Approved: TELMISARTAN — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals Limited's supplemental application for telmisartan, enabling marketing of the generic product.

• FDA approval · 2015-10-07
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Micro Labs Limited)

  FDA approves a supplemental application for Losartan Potassium by Micro Labs Limited.

• FDA approval · 2015-10-02
  FDA Approved: COREG CR — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG CR (carvedilol phosphate) from Waylis Therapeutics LLC, approving the controlled-release f…

• FDA approval · 2015-10-02
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

  The FDA approved a supplemental application for COREG (carvedilol) submitted by Waylis Therapeutics LLC.

• FDA approval · 2015-10-02
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s supplemental application for amlodipine besylate as a generic product under an ANDA, expanding its availabilit…

• FDA approval · 2015-10-02
  FDA Approved: NIFEDIPINE — Supplemental Application (Leading Pharma, LLC)

  FDA approved a supplemental application for a nifedipine product from Leading Pharma, LLC, associated with an approved generic (ANDA074045).

• FDA approval · 2015-09-25
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (PD-Rx Pharmaceuticals, Inc.)

  FDA approved a supplemental application for amlodipine besylate by PD-Rx Pharmaceuticals, Inc. under ANDA 076719, allowing marketing of this…