Hypertension

• FDA approval · 2023-04-25
  FDA Approved: TELMISARTAN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application for Telmisartan submitted by Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2023-04-20
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Spironolactone and Hydrochlorothiazide by Mylan Pharmaceuticals Inc., potentially updating label…

• FDA approval · 2023-04-14
  FDA Approved: KAPSPARGO — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for KAPSPARGO (metoprolol succinate) by Sun Pharmaceutical Industries.

• FDA approval · 2023-04-11
  FDA Approved: AMLODIPINE AND VALSARTAN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application from Mylan Pharmaceuticals for a generic amlodipine/valsartan combination product.

• EMA approval · 2023-04-11
  EMA Authorised: Granpidam (sildenafil citrate) — Accord Healthcare S.L.U.

  Granpidam (sildenafil citrate) has been authorised in the EU for use in hypertension and pulmonary hypertension with Accord Healthcare S.L.U…

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• FDA approval · 2023-03-30
  FDA Approved: NEBIVOLOL — Original Application (Apnar Pharma LP)

  The FDA approved nebivolol hydrochloride as a generic drug under an original ANDA filed by Apnar Pharma LP.

• FDA approval · 2023-03-22
  FDA Approved: AMLODIPINE AND VALSARTAN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for a combination product containing amlodipine and valsartan.

• FDA approval · 2023-03-21
  FDA Approved: TELMISARTAN — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Telmisartan submitted by Zydus Lifesciences Limited.

• FDA approval · 2023-03-17
  FDA Approved: HYZAAR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for HYZAAR (losartan potassium and hydrochlorothiazide) from Organon LLC. The approval pertains to c…

• FDA approval · 2023-03-17
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for the Lisinopril and Hydrochlorothiazide combination from Lupin Pharmaceuticals, formalizing an ap…

• FDA approval · 2023-03-16
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Hydrochlorothiazide submitted by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals In…

• FDA approval · 2023-03-15
  FDA Approved: AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for a fixed-dose combination of amlodipine and benazepril hydrochloride manufactured by Rising Pharm…

• FDA approval · 2023-03-10
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  The FDA approved a supplemental application for Toprol XL (metoprolol succinate) submitted by Melinta Therapeutics, LLC.

• FDA approval · 2023-03-10
  FDA Approved: TELMISARTAN — Supplemental Application (Solco Healthcare US, LLC)

  FDA approved a supplemental application for telmisartan submitted by Solco Healthcare US, LLC.

• FDA approval · 2023-03-07
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals, LLC)

  FDA approved Slate Run Pharmaceuticals, LLC's generic diltiazem hydrochloride through an original ANDA.

• FDA approval · 2023-03-06
  FDA Approved: PRAZOSIN HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals Limited's original application for prazosin hydrochloride, making a generic prazosin hydrochloride prod…

• FDA approval · 2023-03-01
  FDA Approved: OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental ANDA for a generic fixed-dose combination of olmesartan medoxomil, amlodipine, and hydrochlorothiazide for hyper…

• FDA approval · 2023-03-01
  FDA Approved: OLMESARTAN MEDOXOMIL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark Pharmaceuticals Inc., USA's supplemental application for olmesartan medoxomil (ANDA 203281), a generic antihyperte…

• FDA approval · 2023-03-01
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith's generic diltiazem hydrochloride (Original Application) as a generic version of diltiazem hydrochloride.

• FDA approval · 2023-02-27
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for metoprolol succinate from Actavis Pharma, Inc., authorizing a generic extended-release metoprolo…

• FDA approval · 2023-02-23
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Solco Healthcare US, LLC)

  FDA approved a supplemental application for the generic irbesartan and hydrochlorothiazide from Solco Healthcare US, LLC, to maintain/expand…

• FDA approval · 2023-02-23
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Solco Healthcare US, LLC)

  FDA approved a supplemental application for the generic Losartan Potassium and Hydrochlorothiazide from Solco Healthcare US, LLC.

• FDA approval · 2023-02-23
  FDA Approved: LOSARTAN POTASSIUM — Original Application (Granules Pharmaceuticals Inc.)

  FDA approved Granules Pharmaceuticals Inc.'s original ANDA for Losartan Potassium tablets, authorizing a generic version of losartan potassi…

• FDA approval · 2023-02-17
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for the generic Spironolactone and Hydrochlorothiazide from Mylan Pharmaceuticals Inc., a combinatio…

• FDA approval · 2023-02-13
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Original Application (Eugia US LLC)

  FDA approved Hydralazine hydrochloride as an original-application generic (ANDA) from Eugia US LLC.