Hypertension

• FDA approval · 2016-11-04
  FDA Approved: ALISKIREN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Aliskiren Hemifumarate from Prasco Laboratories.

• FDA approval · 2016-11-03
  FDA Approved: OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a generic fixed-dose combination tablet of olmesartan medoxomil, amlodipine, and hydrochlorothiazide under an Original Applicat…

• FDA approval · 2016-11-01
  FDA Approved: TRIBENZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Tribenzor (olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide) by Cosette Phar…

• FDA approval · 2016-11-01
  FDA Approved: BENICAR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

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

• FDA approval · 2016-11-01
  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., appr…

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• FDA approval · 2016-10-28
  FDA Approved: AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s original ANDA for a generic combination of amlodipine besylate and olmesartan medoxomil for hypertensi…

• FDA approval · 2016-10-26
  FDA Approved: OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE — Original Application (Par Health USA, LLC)

  The FDA approved a generic fixed-dose combination tablet containing olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide for h…

• FDA approval · 2016-10-26
  FDA Approved: AMLODIPINE AND OLMESARTAN MEDOXOMIL — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved Macleods Pharmaceuticals Limited's combination product amlodipine and olmesartan medoxomil as an original application, providin…

• FDA approval · 2016-10-24
  FDA Approved: EDARBYCLOR — Supplemental Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  The FDA approved a supplemental application for EDARBYCLOR (azilsartan medoxomil and chlorthalidone) filed by Azurity Pharmaceuticals, appro…

• FDA approval · 2016-10-24
  FDA Approved: EDARBI — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  FDA approved a supplemental application for EDARBI (AZILSARTAN KAMEDOXOMIL) from Azurity Pharmaceuticals, Inc.

• FDA approval · 2016-10-14
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Hisun Pharmaceuticals USA Inc.)

  FDA approved a generic fixed-dose combination tablet of irbesartan and hydrochlorothiazide from Hisun Pharmaceuticals USA Inc. for hypertens…

• FDA approval · 2016-10-12
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Alembic Pharmaceuticals Limited)

  The FDA approved Alembic Pharmaceuticals Limited's original application for a generic irbesartan/hydrochlorothiazide combination tablet for …

• FDA approval · 2016-10-07
  FDA Approved: FUROSEMIDE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  FDA approved a supplemental NDA for furosemide submitted by Marlex Pharmaceuticals, Inc.

• FDA approval · 2016-09-26
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a generic fixed-dose combination of irbesartan and hydrochlorothiazide from Aurobindo Pharma Lim…

• FDA approval · 2016-09-23
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for nicardipine hydrochloride (Hikma Pharmaceuticals USA Inc.), resulting in labeling changes fo…

• FDA approval · 2016-09-22
  FDA Approved: FUROSEMIDE — Supplemental Application (Hospira, Inc.)

  FDA approves Hospira, Inc.'s supplemental application for furosemide, initiating a supplemental approval for the drug. The action updates th…

• FDA approval · 2016-09-22
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for the Irbesartan and Hydrochlorothiazide combination by Macleods Pharmaceuticals Limited.

• FDA approval · 2016-09-22
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Solco Healthcare US, LLC)

  FDA approved a supplemental application for IRBESARTAN AND HYDROCHLOROTHIAZIDE, a fixed-dose combination for treating hypertension.

• FDA approval · 2016-09-20
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for the fixed-dose combination irbesartan and hydrochlorothiazide (Teva). The product is used to tre…

• FDA approval · 2016-09-19
  FDA Approved: FUROSEMIDE — Supplemental Application (Phlow Corporation)

  FDA approved a supplemental application for furosemide submitted by Phlow Corporation.

• FDA approval · 2016-09-19
  FDA Approved: SPIRONOLACTONE — Original Application (Accord Healthcare, Inc.)

  FDA approves Accord Healthcare, Inc.'s original application for spironolactone (generic), authorizing its use as a potassium-sparing diureti…

• FDA approval · 2016-09-16
  FDA Approved: VALSARTAN — Original Application (Macleods Pharmaceuticals Limited)

  The FDA approved the original ANDA for valsartan from Macleods Pharmaceuticals Limited, making a generic ARB option available. This approval…

• FDA approval · 2016-09-15
  FDA Approved: QUINAPRIL — Original Application (Solco Healthcare US, LLC)

  FDA approves the original application for Quinapril, granting approval for a generic version manufactured by Solco Healthcare US, LLC.

• FDA approval · 2016-09-13
  FDA Approved: LISINOPRIL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for lisinopril submitted by Aurobindo Pharma Limited under ANDA 077622.

• FDA approval · 2016-09-08
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  The FDA approved a supplemental application for lisinopril from Solco Healthcare U.S., LLC under an ANDA, confirming the approval of this ge…