Idiopathic Intracranial Hypertension
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CLINICAL_TRIALS trial_result · 2024-08-21Clinical Trial Update: Magnetic Resonance Venography Pre- and Post-Treatment in Patients With Idiopathic Intracranial Hypertension
This completed clinical trial studied magnetic resonance venography before and after treatment in Idiopathic Intracranial Hypertension to as…
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FDA approval · 2024-07-26FDA 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…
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CLINICAL_TRIALS research · 2024-06-12Clinical Trial Update: ICP & Outflow Study
Clinical trial update on an intracranial pressure and outflow study examining eye changes and idiopathic intracranial hypertension; the stud…
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CLINICAL_TRIALS trial_result · 2024-06-06Clinical Trial Update: A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control [NA]
A completed clinical trial from IntuiTap Medical evaluated tactile imaging-guided neuraxial needle placement versus control, with results po…
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CLINICAL_TRIALS research · 2024-05-28Clinical Trial Update: Biomarkers in the Etiology of Idiopathic Intracranial Hypertension [NA]
A clinical trial is investigating biomarkers related to the etiology of idiopathic intracranial hypertension and is currently recruiting at …
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FDA approval · 2024-05-15FDA Approved: ACETAZOLAMIDE — Supplemental Application (Lifestar Pharma LLC)
FDA has approved a supplemental application for acetazolamide submitted by Lifestar Pharma LLC.
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CLINICAL_TRIALS trial_result · 2024-04-24Clinical Trial Update: A Trial to Determine the Efficacy and Safety of Presendin in IIH [Phase 3]
A Phase 3 trial investigating Presendin for idiopathic intracranial hypertension was terminated; results have been posted.
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CLINICAL_TRIALS trial_result · 2024-04-12Clinical Trial Update: Exploratory Study on the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment [Phase 3]
Exploratory Phase 3 trial assessing the efficacy and safety of semaglutide for idiopathic intracranial hypertension has not yet recruited.
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FDA approval · 2023-08-25FDA 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 …
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FDA approval · 2023-08-16FDA 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 …
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FDA approval · 2023-08-16FDA 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…
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FDA approval · 2023-05-24FDA Approved: ACETAZOLAMIDE — Supplemental Application (Chartwell RX, LLC)
The FDA approved a supplemental application for acetazolamide submitted by Chartwell RX, LLC.
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CLINICAL_TRIALS trial_result · 2022-06-16Clinical Trial Update: Surgical Idiopathic Intracranial Hypertension Treatment Trial [Phase 3]
Phase 3 clinical trial for surgical treatment of idiopathic intracranial hypertension was terminated; results posted in 2022.
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CLINICAL_TRIALS trial_result · 2021-10-27Clinical Trial Update: Safety and Effectiveness of 11b-Hydroxysteroid Dehydrogenase Type 1 Inhibitor (AZD4017) to Treat Idiopathic Intracranial Hypertension. [Phase 2]
Phase 2 trial assessing the safety and effectiveness of AZD4017, an 11b-Hydroxysteroid Dehydrogenase Type 1 inhibitor, for idiopathic intrac…
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FDA approval · 2021-08-19FDA 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…
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FDA approval · 2019-10-17FDA Approved: ACETAZOLAMIDE — Original Application (ANI Pharmaceuticals, Inc.)
The FDA approved ANI Pharmaceuticals' Original Application for acetazolamide, granting approval of a generic version.
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CLINICAL_TRIALS trial_result · 2018-12-12Clinical Trial Update: Idiopathic Intracranial Hypertension Treatment Trial [Phase 2, Phase 3]
Clinical trial update for idiopathic intracranial hypertension with Phase 2 and Phase 3 results completed and posted in 2018.
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FDA approval · 2017-11-20FDA Approved: ACETAZOLAMIDE — Original Application (Strides Pharma Science Limited)
FDA approved an original application for acetazolamide from Strides Pharma Science Limited, establishing a generic version of the drug. The …
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CLINICAL_TRIALS trial_result · 2017-08-11Clinical Trial Update: Comparison of Continuous Non-Invasive and Invasive Intracranial Pressure Measurement [NA]
A clinical trial comparing continuous non-invasive versus invasive intracranial pressure measurement was terminated. The study involved pati…
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CLINICAL_TRIALS trial_result · 2017-05-15Clinical Trial Update: Stenting of Venous Sinus Stenosis for Medically Refractory Idiopathic Intracranial Hypertension [NA]
A clinical trial evaluates venous sinus stenting for medically refractory idiopathic intracranial hypertension. The current trial status is …
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CLINICAL_TRIALS research · 2016-08-05Clinical Trial Update: Neurocognitive Outcome in Children Who Suffered From Idiopathic Increased Intracranial Hypertension (IIH) [NA]
Trial update describing neurocognitive outcomes in children with idiopathic intracranial hypertension; current status of the study is listed…
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CLINICAL_TRIALS research · 2016-01-28Clinical Trial Update: OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension [NA]
The study, sponsored by Hillel Yaffe Medical Center, investigates OCT imaging of papilledema in children with idiopathic intracranial hypert…
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CLINICAL_TRIALS research · 2014-05-29Clinical Trial Update: Antiacne Medications Pseudotumor Cerebri [Phase 4]
Phase 4 clinical trial update on antiacne medications and pseudotumor cerebri (idiopathic intracranial hypertension), with optic disc swelli…
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FDA approval · 2011-07-14FDA Approved: ACETAZOLAMIDE — Original Application (Westminster Pharmaceuticals, LLC)
FDA approved the original ANDA for Acetazolamide from Westminster Pharmaceuticals, making a generic version of the carbonic anhydrase inhibi…
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FDA approval · 2008-12-10FDA Approved: ACETAZOLAMIDE — Original Application (XGen Pharmaceuticals DJB, Inc.)
FDA approves a generic acetazolamide product (Diamox) from XGen Pharmaceuticals DJB, Inc. under an Original Application.