Hypertension

• FDA approval · 2016-01-19
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for amlodipine besylate from Unichem Pharmaceuticals (USA), Inc. to bring a generic product to marke…

• FDA approval · 2016-01-12
  FDA Approved: MICARDIS HCT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approves a supplemental application for MICARDIS HCT (telmisartan/hydrochlorothiazide) from Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA approval · 2016-01-11
  FDA Approved: VALSARTAN — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal Pharmaceuticals LLC's Original Application for VALSARTAN, authorizing the marketing of a generic valsartan product.

• FDA approval · 2016-01-08
  FDA Approved: PRAZOSIN HYDROCHLORIDE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Prazosin hydrochloride submitted by Prasco Laboratories. This action updates the regulatory …

• FDA approval · 2016-01-05
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Hydralazine hydrochloride (Camber Pharmaceuticals, Inc.), confirming regulatory approval for an …

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• FDA approval · 2016-01-05
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for a generic fixed-dose combination of spironolactone and hydrochlorothiazide produced by Mylan Pha…

• FDA approval · 2016-01-04
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  FDA approved a supplemental application for lisinopril from Solco Healthcare U.S., LLC, supporting continued availability of the generic ACE…

• FDA approval · 2016-01-04
  FDA Approved: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  The FDA approved a supplemental application for a generic fixed-dose combination of amlodipine besylate and benazepril hydrochloride from Dr…

• FDA approval · 2016-01-04
  FDA Approved: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for a fixed-dose combination of amlodipine besylate and benazepril hydrochloride from Dr. Reddy's La…

• FDA approval · 2016-01-04
  FDA Approved: AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental ANDA for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE from Rising Pharma Holdings, Inc., authorizing continued market…

• FDA approval · 2016-01-04
  FDA Approved: AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for a generic fixed-dose combination of amlodipine and benazepril hydrochloride, enabling contin…

• FDA approval · 2015-12-22
  FDA Approved: ALISKIREN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application from Prasco Laboratories for a generic aliskiren hemifumarate product. The approval expands access t…

• FDA approval · 2015-12-21
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approves a supplemental application for Inderal LA (propranolol hydrochloride) by ANI Pharmaceuticals, Inc., granting approval for chang…

• FDA approval · 2015-12-21
  FDA Approved: CARDENE IV — Supplemental Application (Baxter Healthcare Corporation)

  FDA approves Baxter's supplemental application for Cardene IV, an intravenous formulation of nicardipine hydrochloride. The new IV product e…

• FDA approval · 2015-12-21
  FDA Approved: AMLODIPINE AND VALSARTAN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for a generic fixed-dose combination of amlodipine and valsartan. This appr…

• FDA approval · 2015-12-21
  FDA Approved: EXFORGE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for EXFORGE (amlodipine besylate and valsartan) submitted by Novartis, updating the product labeling…

• FDA approval · 2015-12-21
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for amlodipine besylate from Cipla USA Inc., effectively approving a generic formulation of amlodipi…

• FDA approval · 2015-12-21
  FDA Approved: AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for a generic amlodipine/valsartan/hydrochlorothiazide tablet for the treatment…

• FDA approval · 2015-12-18
  FDA Approved: NADOLOL — Original Application (Cipla USA Inc.)

  FDA approved Nadolol from Cipla USA Inc. as an original generic application (ANDA). Nadolol is used for hypertension and to prevent esophage…

• FDA approval · 2015-12-17
  FDA Approved: LOTENSIN — Supplemental Application (Validus Pharmaceuticals LLC)

  The FDA approved a supplemental application for LOTENSIN (benazepril hydrochloride) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2015-12-17
  FDA Approved: VALSARTAN — Supplemental Application (Ohm Laboratories Inc.)

  FDA approved a supplemental application for VALSARTAN from Ohm Laboratories Inc. (ANDA077492).

• FDA approval · 2015-12-16
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for metoprolol succinate by Quallent Pharmaceuticals Health LLC, indicating approval of the suppleme…

• FDA approval · 2015-12-11
  FDA Approved: HYZAAR — Supplemental Application (Organon LLC)

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

• FDA approval · 2015-12-11
  FDA Approved: VALSARTAN — Supplemental Application (Alembic Pharmaceuticals Limited)

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

• FDA approval · 2015-12-10
  FDA Approved: AMLODIPINE BESYLATE — Original Application (Exelan Pharmaceuticals, Inc.)

  FDA approves the Original Application for amlodipine besylate, a generic version of the calcium channel blocker used to treat hypertension a…