Hypertension

• FDA approval · 2021-04-23
  FDA Approved: IRBESARTAN — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for Irbesartan from Unichem Pharmaceuticals USA, Inc., indicating regulatory approval of a modif…

• FDA approval · 2021-04-21
  FDA Approved: LOTREL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Lotrel (amlodipine besylate and benazepril hydrochloride) from Novartis Pharmaceuticals Corporat…

• FDA approval · 2021-04-16
  FDA Approved: CLEVIPREX — Supplemental Application (Fresenius Kabi Austria GmbH)

  FDA approved a supplemental application for CLEVIPREX (clevidipine) from Fresenius Kabi Austria GmbH. The action involves a labeling/indicat…

• FDA approval · 2021-04-08
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Original Application (Eugia US LLC)

  FDA approved Eugia US LLC's original ANDA for nicardipine hydrochloride as a generic product, enabling marketing of the generic once authori…

• FDA approval · 2021-04-05
  FDA Approved: AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for Strides Pharma Science Limited for a generic fixed-dose combination tablet containing amlodipine…

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• FDA approval · 2021-04-02
  FDA Approved: RAMIPRIL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for ramipril (generic ACE inhibitor), enabling continued marketing with the…

• FDA approval · 2021-04-02
  FDA Approved: RAMIPRIL — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Ramipril from Rising Pharma Holdings, Inc., indicating an updated approval under the ANDA.

• FDA approval · 2021-03-30
  FDA Approved: METOLAZONE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approves the original ANDA for Metolazone from Unichem Pharmaceuticals (USA), Inc., establishing its generic status.

• FDA approval · 2021-03-30
  FDA Approved: METOLAZONE — Original Application (Method Pharmaceuticals, LLC)

  FDA approved METOLAZONE under an original ANDA from Method Pharmaceuticals, LLC (generic approval).

• FDA approval · 2021-03-22
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (GLENMARK PHARMACEUTICALS INC., USA)

  FDA approves Glenmark's diltiazem hydrochloride as an original ANDA; the product is a generic calcium channel blocker indicated for hyperten…

• FDA approval · 2021-03-04
  FDA Approved: LISINOPRIL — Original Application (Chartwell RX, LLC)

  FDA approves Chartwell RX, LLC’s original application for lisinopril, a generic ACE inhibitor. Lisinopril is used to treat hypertension, con…

• FDA approval · 2021-03-03
  FDA Approved: GUANFACINE HYDROCHLORIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a generic formulation of guanfacine hydrochloride under an Original Application (ANDA 214689) for Unichem Pharmaceuticals (USA)…

• FDA approval · 2021-03-02
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for the fixed-dose combination of bisoprolol fumarate and hydrochlorothiazide (Teva). This appro…

• FDA approval · 2021-03-02
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Verapamil Hydrochloride by Mylan Pharmaceuticals, signaling approval of an updated or additional…

• FDA approval · 2021-02-26
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for spironolactone from Mylan Pharmaceuticals, resulting in changes to the product labeling as p…

• FDA approval · 2021-02-26
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for Accord Healthcare's generic spironolactone. This action confirms approval of modifications under…

• FDA approval · 2021-02-26
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  The FDA approved a supplemental application for spironolactone from Oxford Pharmaceuticals, LLC, under the existing ANDA.

• FDA approval · 2021-02-19
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Spironolactone and Hydrochlorothiazide by Prasco Laboratories, authorizing its marketing as …

• FDA approval · 2021-02-12
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Epic Pharma, LLC)

  FDA approves the original application for metoprolol succinate as a generic extended-release beta-blocker indicated for hypertension and hea…

• FDA approval · 2021-01-27
  FDA Approved: FUROSEMIDE — Original Application (Sagent Pharmaceuticals)

  FDA approved a new generic version of furosemide from Sagent Pharmaceuticals under an original application, enabling market entry as a loop …

• FDA approval · 2021-01-25
  FDA Approved: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for olmesartan medoxomil and hydrochlorothiazide, a combination antihypertensive product from Aurobi…

• FDA approval · 2021-01-25
  FDA Approved: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Lifestar Pharma LLC)

  The FDA approved a supplemental application for the combination drug olmesartan medoxomil and hydrochlorothiazide manufactured by Lifestar P…

• FDA approval · 2021-01-21
  FDA Approved: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  The FDA approved Alembic Pharmaceuticals' supplemental application to market a generic fixed-dose combination of olmesartan medoxomil and hy…

• FDA approval · 2021-01-21
  FDA Approved: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for the combination product olmesartan medoxomil and hydrochlorothiazide from Accord Healthcare Inc.

• FDA approval · 2021-01-07
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for the fixed-dose combination of amlodipine besylate and atorvastatin calcium, manufactured by …