Hypertensive Emergency

• CLINICAL_TRIALS research · 2024-10-09
  Clinical Trial Update: Optic Nerve Sheath Diameter in Hypertensive Emergency

  A Leiden University Medical Center trial is investigating optic nerve sheath diameter as a biomarker in hypertensive emergency; the study st…

• CLINICAL_TRIALS trial_result · 2023-06-28
  Clinical Trial Update: a Study Evaluating the Safety and Efficacy of Clevidipine for Patients Who With Hypertensive Emergency and Sub-emergency [Phase 3]

  A Phase 3 clinical trial evaluating the safety and efficacy of Clevidipine for hypertensive emergency is underway.

• CLINICAL_TRIALS trial_result · 2023-03-24
  Clinical Trial Update: A Study of Clevidipine Butyrate Injectable Emulsion in the Treatment of Hypertensive Emergency and Sub-emergency [Phase 3]

  Phase 3 trial evaluating clevidipine butyrate injectable emulsion for hypertensive emergency; current status unknown.

• CLINICAL_TRIALS trial_result · 2021-09-14
  Clinical Trial Update: Clinical Study of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergency and Sub-emergency [Phase 3]

  A Phase 3 clinical study evaluating clevidipine butyrate injection for hypertensive emergency is ongoing; current status is unknown.

• FDA approval · 2021-07-12
  FDA Approved: SODIUM NITROPRUSSIDE — Original Application (BE Pharmaceuticals Inc.)

  FDA approved BE Pharmaceuticals Inc.'s original application for a generic sodium nitroprusside product.

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• 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…

• CLINICAL_TRIALS trial_result · 2020-12-17
  Clinical Trial Update: Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies [Phase 3]

  A Phase 3 trial update evaluating the safety and efficacy of Clevidipine Butyrate Injection for hypertensive emergencies.

• FDA approval · 2020-06-11
  FDA Approved: SODIUM NITROPRUSSIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for a generic sodium nitroprusside product manufactured by Mylan Institutional LLC.

• FDA approval · 2019-11-29
  FDA Approved: SODIUM NITROPRUSSIDE — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved Meitheal Pharmaceuticals' generic sodium nitroprusside under an Original Application (ANDA) for sale as a vasodilator to rapidl…

• FDA approval · 2018-08-17
  FDA Approved: SODIUM NITROPRUSSIDE — Original Application (Somerset Therapeutics, LLC)

  FDA approved the original ANDA for Sodium nitroprusside from Somerset Therapeutics, LLC, authorizing a generic IV vasodilator for use in hyp…

• FDA label_change · 2018-07-13
  FDA Approved: NIPRIDE RTU — Supplemental Application (EXELA PHARMA SCIENCES, LLC)

  FDA approved a supplemental application for Nipride RTU (sodium nitroprusside) from Exela Pharma Sciences, LLC, updating labeling. Nipride R…

• FDA approval · 2018-04-17
  FDA Approved: SODIUM NITROPRUSSIDE — Original Application (Mylan Institutional LLC)

  FDA approved the original application for sodium nitroprusside from Mylan Institutional LLC, introducing a generic version of this vasodilat…

• FDA approval · 2017-12-08
  FDA Approved: SODIUM NITROPRUSSIDE — Original Application (Micro Labs Limited)

  FDA approved Micro Labs Limited's original ANDA for a generic sodium nitroprusside injection. Sodium nitroprusside is a vasodilator used to …

• FDA approval · 2017-11-07
  FDA Approved: SODIUM NITROPRUSSIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal Pharmaceuticals LLC's original application for a generic sodium nitroprusside product.

• CLINICAL_TRIALS trial_result · 2016-10-05
  Clinical Trial Update: Telemedical Versus Conventional Emergency Care of Hypertensive Emergencies

  A completed clinical trial comparing telemedical versus conventional emergency care for hypertensive emergencies and hypertensive urgencies.

• CLINICAL_TRIALS trial_result · 2016-03-14
  Clinical Trial Update: The Effect of Pre-discharge Blood Pressure of Patients With Asymptomatic Severe Hypertension in Emergency Department

  This trial evaluated the effect of pre-discharge blood pressure management in patients with asymptomatic severe hypertension in the emergenc…

• CLINICAL_TRIALS trial_result · 2015-11-16
  Clinical Trial Update: Post Marketing Study to Evaluate the Two Dose Regimens of Nicardipine Injection in Hypertensive Emergency Patients [Phase 4]

  Phase 4 post-marketing study evaluating two dose regimens of nicardipine injection in hypertensive emergency patients with end-organ damage …

• FDA approval · 2013-11-08
  FDA Approved: CLEVIPREX — Supplemental Application (Fresenius Kabi Austria GmbH)

  The FDA approved a supplemental application for CLEVIPREX (clevidipine), submitted by Fresenius Kabi Austria GmbH. The action is categorized…

• 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…