Otitis Media
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-09-27FDA Approved: CEPHALEXIN — Original Application (Ascend Laboratories, LLC)
FDA approved an original application for Cepalexin (cephalexin) from Ascend Laboratories, LLC, establishing a generic cephalexin product.
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FDA approval · 2024-09-27FDA Approved: CEPHALEXIN — Original Application (Aurobindo Pharma Limited)
FDA approved the original application for Cephalexin from Aurobindo Pharma Limited.
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CLINICAL_TRIALS trial_result · 2024-08-22Clinical Trial Update: LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media [NA]
A ClinicalTrials.gov update reports the completion of a study evaluating LiveSpo Navax for acute rhinosinusitis and otitis media within uppe…
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CLINICAL_TRIALS research · 2024-07-23Clinical Trial Update: Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
A prospective, multi-center registry evaluating outcomes after in-office tympanostomy using the Tula System; the study is currently recruiti…
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CLINICAL_TRIALS research · 2024-07-17Clinical Trial Update: Respiratory Tract Microbiome and Probiotics in Children With Cleft Palate [NA]
This clinical trial investigates the respiratory tract microbiome and probiotics in children with cleft palate and otitis media; the study i…
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FDA approval · 2024-07-11FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Micro Labs Limited)
FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium from Micro Labs Limited under ANDA217805.
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CLINICAL_TRIALS trial_result · 2024-07-11Clinical Trial Update: Earset Healthy Volunteer Study
Completed clinical trial in healthy volunteers evaluating Earset for Otitis Media.
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CLINICAL_TRIALS research · 2024-07-09Clinical Trial Update: Does Topical Otic Drop Use at Time of Tympanostomy Tube Surgery Improve Outcomes When no Middle Ear Effusion is Present [Phase 4]
This ClinicalTrials.gov entry describes a Phase 4 trial evaluating the use of topical otic drops at the time of tympanostomy tube surgery in…
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CLINICAL_TRIALS trial_result · 2024-07-03Clinical Trial Update: Delayed Antibiotic Therapy in General Practice
A completed clinical trial examined whether delaying antibiotic therapy is effective for acute otitis media in general practice.
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FDA approval · 2024-06-24FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for sulfamethoxazole and trimethoprim by Prasco Laboratories. This action confirms the approval of t…
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FDA approval · 2024-06-24FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium by Sandoz Inc to support changes to the approved gener…
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CLINICAL_TRIALS trial_result · 2024-05-13Clinical Trial Update: Analgesic Ear Drops for Children With Acute Otitis Media [Phase 3]
Phase 3 trial of analgesic ear drops for children with acute otitis media was terminated.
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CLINICAL_TRIALS research · 2024-05-09Clinical Trial Update: Validation of a Questionnaire for Measuring Quality of Life in Patients With Chronic Inflammation of the Middle Ear
The document reports on the validation of a quality-of-life questionnaire for patients with chronic otitis media, based on data from a compl…
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CLINICAL_TRIALS trial_result · 2024-05-03Clinical Trial Update: Bone Anchored Hearing Implants in Chronic Otitis Media
Clinical trial update indicating completion of a study evaluating bone-anchored hearing implants for hearing loss associated with chronic ot…
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FDA approval · 2024-05-01FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Northstar RxLLC)
FDA approved a supplemental application for Amoxicillin and clavulanate potassium (amoxicillin-clavulanate) from Northstar RxLLC, authorizin…
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FDA approval · 2024-04-25FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (NorthStar Rx LLC)
FDA approved a Supplemental Application for Amoxicillin and clavulanate potassium by NorthStar Rx LLC, indicating a modification to an exist…
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FDA approval · 2024-04-25FDA Approved: AMOXICILLIN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for amoxicillin submitted by Hikma Pharmaceuticals USA Inc.
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CLINICAL_TRIALS trial_result · 2024-04-25Clinical Trial Update: Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India [Phase 4]
A Phase 4 study conducted in India assessed the safety and clinical efficacy of Augmentin Extra Strength-600 (amoxicillin/clavulanic acid) i…
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FDA approval · 2024-04-24FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium from Teva Pharmaceuticals USA, Inc.
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FDA approval · 2024-04-09FDA Approved: CEFPROZIL — Original Application (Ascend Laboratories, LLC)
FDA approved the original application for cefprozil from Ascend Laboratories, LLC, confirming it as a generic cephalosporin antibiotic.
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FDA approval · 2024-03-22FDA Approved: CIPROFLOXACIN AND DEXAMETHASONE — Original Application (Amneal Pharmaceuticals of New York LLC)
FDA approved ciprofloxacin and dexamethasone otic suspension from Amneal as a generic (ANDA) product.
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FDA approval · 2023-12-11FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Devatis, Inc.)
FDA approved an Original Application for amoxicillin and clavulanate potassium (amoxicillin/clavulanate) as a generic antibiotic formulation…
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FDA approval · 2023-10-31FDA Approved: AMPICILLIN — Original Application (Aurobindo Pharma Limited)
FDA approved an original application for Ampicillin from Aurobindo Pharma Limited, granting marketing authorization for a generic ampicillin…
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FDA approval · 2023-09-15FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Devatis, Inc.)
FDA approves a generic amoxicillin/clavulanate potassium product under an Original Application by Devatis, Inc.
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FDA approval · 2023-09-13FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Devatis Inc.)
FDA approved a generic Amoxicillin and clavulanate potassium product under Original Application by Devatis Inc.