Hypertension

• FDA approval · 2012-05-10
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for furosemide submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2012-05-09
  FDA Approved: FUROSEMIDE — Supplemental Application (Solco Healthcare LLC)

  FDA approved a supplemental application for furosemide from Solco Healthcare LLC, authorizing continued production and marketing of the gene…

• FDA approval · 2012-05-02
  FDA Approved: ZESTORETIC — Supplemental Application (Almatica Pharma Inc.)

  The FDA approved a supplemental application for Zestoretic, the lisinopril/hydrochlorothiazide combination from Almatica Pharma Inc.

• FDA approval · 2012-04-27
  FDA Approved: ATACAND — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' supplemental application for ATACAND (candesartan cilexetil). This action updates the drug's labeling as p…

• FDA approval · 2012-04-16
  FDA Approved: ALISKIREN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for aliskiren hemifumarate filed by Prasco Laboratories. This action updates the regulatory status o…

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• FDA approval · 2012-04-10
  FDA Approved: EDARBYCLOR — Supplemental Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  The FDA approved a supplemental application for Edarbyclor, a fixed-dose combination of azilsartan medoxomil and chlorthalidone, developed b…

• FDA approval · 2012-04-03
  FDA Approved: LABETALOL HYDROCHLORIDE — Original Application (Fosun Pharma USA Inc.)

  The FDA approved the original ANDA for labetalol hydrochloride (generic) by Fosun Pharma USA Inc., authorizing its marketing as a generic an…

• FDA approval · 2012-03-30
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's irbesartan and hydrochlorothiazide as an original ANDA, providing a generic version of the combination therapy for hyper…

• FDA approval · 2012-03-29
  FDA Approved: CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for candesartan cilexetil and hydrochlorothiazide from ANI Pharmaceuticals, Inc. The approval co…

• FDA approval · 2012-03-29
  FDA Approved: ZESTORETIC — Supplemental Application (Almatica Pharma Inc.)

  FDA approved a supplemental application for ZESTORETIC (lisinopril and hydrochlorothiazide) submitted by Almatica Pharma Inc.

• FDA approval · 2012-03-29
  FDA Approved: ZESTRIL — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for Zestril (lisinopril) submitted by Upsher-Smith Laboratories.

• FDA approval · 2012-03-27
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for LASIX (furosemide) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2012-02-23
  FDA Approved: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Dr.Reddy's Laboratories Limited)

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

• FDA approval · 2012-02-17
  FDA Approved: VASERETIC — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for VASERETIC (enalapril maleate and hydrochlorothiazide) from Bausch Health US, LLC. The action per…

• FDA approval · 2012-02-17
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves the original application for Losartan Potassium and Hydrochlorothiazide combination tablets from Alembic Pharmaceuticals Limite…

• FDA approval · 2012-02-16
  FDA Approved: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental NDA for Benazepril hydrochloride and hydrochlorothiazide (Padagis US LLC).

• FDA approval · 2012-02-16
  FDA Approved: DIOVAN HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approves a supplemental application for DIOVAN HCT (valsartan/hydrochlorothiazide) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2012-02-15
  FDA Approved: BENICAR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved Cosette Pharmaceuticals' supplemental application for Benicar (olmesartan medoxomil), resulting in an approved update to th…

• FDA approval · 2012-02-09
  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. This action represent…

• FDA approval · 2012-02-02
  FDA Approved: ALISKIREN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for aliskiren hemifumarate from Prasco Laboratories, making a generic version of aliskiren avail…

• FDA approval · 2012-01-27
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for propranolol hydrochloride from Ipca Laboratories Limited, finalizing a regulatory update for the…

• FDA approval · 2012-01-27
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Endo USA, Inc.)

  FDA approved Endo USA, Inc.'s supplemental application for propranolol hydrochloride, indicating the generic product's supplemental filing h…

• FDA approval · 2012-01-26
  FDA Approved: ALISKIREN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for a generic version of aliskiren hemifumarate by Prasco Laboratories.

• FDA approval · 2012-01-23
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for carvedilol, a generic beta-blocker, for a new or expanded generic…

• FDA approval · 2012-01-20
  FDA Approved: MICARDIS HCT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for MICARDIS HCT (telmisartan/hydrochlorothiazide) submitted by Boehringer Ingelheim Pharmaceuticals…