Hypertension

• FDA approval · 2016-09-02
  FDA Approved: TELMISARTAN AND AMLODIPINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for a generic fixed-dose combination of telmisartan and amlodipine for hyperten…

• FDA approval · 2016-08-29
  FDA Approved: VALSARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for Valsartan and Hydrochlorothiazide from Macleods Pharmaceuticals Limited, updating the approv…

• FDA approval · 2016-08-26
  FDA Approved: CARDENE IV — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for Cardene IV (nicardipine hydrochloride) from Baxter Healthcare Corporation, enabling an additiona…

• FDA approval · 2016-08-25
  FDA Approved: NIFEDIPINE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approves Ingenus Pharmaceuticals' original application for a generic nifedipine product, enabling its marketing for hypertension and ang…

• FDA approval · 2016-08-22
  FDA Approved: TELMISARTAN — Original Application (Jubilant Cadista Pharmacuticals Inc.)

  The FDA approves Jubilant Cadista Pharmaceuticals Inc.'s generic telmisartan (Original Application) for U.S. use as an angiotensin II recept…

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• FDA approval · 2016-08-22
  FDA Approved: IRBESARTAN — Supplemental Application (Solco Healthcare U.S., LLC)

  FDA approved a supplemental application for IRBESARTAN from Solco Healthcare U.S., LLC.

• FDA approval · 2016-08-22
  FDA Approved: GUANFACINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for guanfacine hydrochloride from Aurobindo Pharma Limited, authorizing changes to the approved …

• FDA approval · 2016-08-19
  FDA Approved: BISOPROLOL FUMARATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved the supplemental application to market a generic bisoprolol fumarate tablet from Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2016-08-09
  FDA Approved: IRBESARTAN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for IRBESARTAN, a generic irbesartan product.

• FDA approval · 2016-08-09
  FDA Approved: IRBESARTAN — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for IRBESARTAN by NorthStar RxLLC, approving an update to the already approved generic product.

• FDA approval · 2016-08-01
  FDA Approved: DIOVAN HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2016-07-29
  FDA Approved: QBRELIS — Original Application (Azurity Pharmaceuticals, Inc.)

  The FDA approved QBRELIS (lisinopril) through an original NDA from Azurity Pharmaceuticals. It is indicated for hypertension, heart failure,…

• FDA approval · 2016-07-20
  FDA Approved: FUROSEMIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original application for furosemide, authorizing a generic version of this diuretic.

• FDA approval · 2016-07-15
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for metoprolol succinate from BluePoint Laboratories, enabling continued marketing of this generic b…

• FDA approval · 2016-07-13
  FDA Approved: LISINOPRIL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901))

  FDA approved a supplemental application for lisinopril from Heritage Pharmaceuticals (Avet) under ANDA 076102 to authorize the generic produ…

• FDA approval · 2016-07-11
  FDA Approved: AMLODIPINE BESYLATE — Original Application (POLYGEN PHARMACEUTICALS INC.)

  FDA approved the original application for amlodipine besylate by Polygen Pharmaceuticals Inc., broadening access to a generic calcium channe…

• FDA approval · 2016-07-08
  FDA Approved: AZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2016-07-08
  FDA Approved: BENICAR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for BENICAR (olmesartan medoxomil) submitted by Cosette Pharmaceuticals, Inc.

• FDA approval · 2016-06-29
  FDA Approved: VALSARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for VALSARTAN AND HYDROCHLOROTHIAZIDE by Alembic Pharmaceuticals Limited.

• FDA approval · 2016-06-23
  FDA Approved: CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for a generic fixed-dose combination of candesartan cilexetil and hydrochlorothiazide by Macleods Ph…

• FDA approval · 2016-06-14
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for a generic fixed-dose combination of spironolactone and hydrochlorothiazide from Mylan Pharma…

• FDA approval · 2016-06-14
  FDA Approved: IRBESARTAN — Original Application (Hisun Pharmaceuticals USA Inc.)

  FDA approved the original application for IRBESARTAN (generic irbesartan) by Hisun Pharmaceuticals USA Inc., marking approval of the generic…

• FDA approval · 2016-06-13
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for metoprolol succinate (generic) from Mylan Pharmaceuticals Inc., resulting in labeling changes as…

• FDA approval · 2016-06-10
  FDA Approved: BENICAR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved Cosette Pharmaceuticals' supplemental application for BENICAR (olmesartan medoxomil), resulting in labeling updates for the pro…

• FDA approval · 2016-06-10
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for losartan potassium submitted by Alembic Pharmaceuticals Limited (ANDA 090428). This action u…