Mountain Sickness

• CLINICAL_TRIALS trial_result · 2024-08-06
  Clinical Trial Update: Risk Factors Associated With High Altitude Sickness: A Case-Control Study

  This completed case-control trial investigates risk factors for high altitude sickness. The study encompasses Acute Mountain Sickness, High …

• FDA approval · 2024-07-26
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for Acetazolamide under ANDA 202693, submitted by Heritage Pharmaceuticals d/b/a Avet Pharmaceutical…

• CLINICAL_TRIALS trial_result · 2024-05-28
  Clinical Trial Update: Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness [Phase 4]

  A Phase 4 clinical trial evaluated the efficacy of oral prochlorperazine as a prophylactic treatment for Acute Mountain Sickness.

• FDA approval · 2024-05-15
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Lifestar Pharma LLC)

  FDA has approved a supplemental application for acetazolamide submitted by Lifestar Pharma LLC.

• FDA label_change · 2024-01-25
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for acetazolamide by Hikma Pharmaceuticals USA Inc., resulting in labeling and/or manufacturing chan…

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• FDA approval · 2023-09-11
  FDA Approved: ACETAZOLAMIDE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s original application for acetazolamide (generic).

• FDA approval · 2023-08-25
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for acetazolamide sodium filed by Mylan Institutional LLC, approving the salt form of acetazolamide …

• FDA approval · 2023-08-16
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (TRUPHARMA, LLC)

  FDA approved a supplemental application for acetazolamide from TRUPHARMA, LLC under ANDA 211372. This action updates the approval status of …

• FDA approval · 2023-08-16
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Eywa Pharma Inc)

  The FDA approved Eywa Pharma Inc's supplemental application for acetazolamide, enabling continued marketing of a generic acetazolamide produ…

• FDA approval · 2023-05-24
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for acetazolamide submitted by Chartwell RX, LLC.

• FDA approval · 2023-05-19
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Acetazolamide from Accord Healthcare Inc., a generic drug.

• FDA approval · 2023-05-09
  FDA Approved: ACETAZOLAMIDE — Original Application (Marlex Pharmaceuticals, Inc.)

  FDA approved acetazolamide as an original ANDA from Marlex Pharmaceuticals, providing a generic version of the carbonic anhydrase inhibitor.…

• FDA approval · 2023-04-04
  FDA Approved: ACETAZOLAMIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved a generic acetazolamide product from Zydus Lifesciences Limited under an Original Application (ANDA211069).

• CLINICAL_TRIALS trial_result · 2023-03-10
  Clinical Trial Update: Colorado-Oregon Altitude Study [Phase 4]

  Phase 4 clinical trial update for Acute Mountain Sickness conducted in Colorado and Oregon, status completed.

• CLINICAL_TRIALS trial_result · 2022-10-03
  Clinical Trial Update: Optimization Strategy for the Prevention of AMS by RIPC Combined With Acetazolamide [Phase 4]

  Phase 4 trial update on optimizing prevention of acute mountain sickness using remote ischemic preconditioning (RIPC) with acetazolamide.

• FDA approval · 2021-08-19
  FDA Approved: ACETAZOLAMIDE — Original Application (Advagen Pharma Ltd)

  FDA approved Advagen Pharma Ltd's generic acetazolamide under an original (ANDA) application, enabling marketing of a generic formulation of…

• CLINICAL_TRIALS trial_result · 2021-05-13
  Clinical Trial Update: Effect of Acetazolamide on Acute Mountain Sickness in Lowlanders Older Than 40 Years [Phase 4]

  Phase 4 clinical trial evaluating the effect of acetazolamide on acute mountain sickness in adults over 40 years old has been completed.

• CLINICAL_TRIALS trial_result · 2021-03-30
  Clinical Trial Update: Three New Ideas to Protect Special Forces From the Stress of High Altitude [Phase 4]

  Phase 4 trial update on three new ideas to protect special forces from high altitude stress; study completed with results posted.

• FDA approval · 2021-02-22
  FDA Approved: ACETAZOLAMIDE — Original Application (TRUPHARMA, LLC)

  The FDA approved an original ANDA for Acetazolamide, a generic version manufactured by TRUPHARMA, LLC.

• FDA approval · 2020-10-01
  FDA Approved: ACETAZOLAMIDE EXTENDED-RELEASE — Original Application (Micro Labs Limited)

  FDA approved an acetazolamide extended-release product as an original application from Micro Labs Limited.

• CLINICAL_TRIALS trial_result · 2019-11-13
  Clinical Trial Update: Safety and Efficacy of T89 in Prevention and Treatment of Adults With Acute Mountain Sickness (AMS) [Phase 2]

  Phase 2 trial update evaluating safety and efficacy of T89 for prevention and treatment of Acute Mountain Sickness has completed.

• FDA approval · 2019-10-18
  FDA Approved: ACETAZOLAMIDE — Original Application (Eywa Pharma Inc)

  FDA approved acetazolamide from Eywa Pharma Inc under an original application (ANDA 211556), making a generic version of the drug available.

• CLINICAL_TRIALS trial_result · 2019-01-29
  Clinical Trial Update: Acetazolamide for the Prevention of High Altitude Illness: a Comparison of Dosing [Phase 4]

  Phase 4 trial comparing dosing regimens of acetazolamide for prevention of acute mountain sickness has completed with results posted.

• FDA approval · 2018-10-18
  FDA Approved: ACETAZOLAMIDE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s Original Application for acetazolamide, confirming a generic version of the drug. The approval allows …

• CLINICAL_TRIALS research · 2018-02-27
  Clinical Trial Update: A Study of the Effect of High Altitudes on Physiological and Metabolic Markers in Adults Living at Qinghai-Tibet Plateau for Work Purpose

  Clinical trial examining the effects of living at high altitude on physiological and metabolic markers in adults on the Qinghai-Tibet Platea…