Otitis Media
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2015-04-08Clinical Trial Update: Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media [Phase 3]
A Phase 3 trial evaluating AR01 versus placebo for pain relief in Acute Otitis Media has completed.
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CLINICAL_TRIALS trial_result · 2015-03-27Clinical Trial Update: Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®) [Phase 4]
Phase 4 trial evaluating off-label use of Dornase alfa (Pulmozyme) for clogged tympanostomy tubes in otitis media; results posted in 2015.
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CLINICAL_TRIALS trial_result · 2015-03-20Clinical Trial Update: Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children [Phase 3]
Phase 3 trial of Xylitol Syrup for preventing acute otitis media in otitis-prone children has completed, with results posted in 2015.
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FDA label_change · 2015-03-16FDA Approved: AUGMENTIN ES-600 — Supplemental Application (USAntibiotics, LLC)
FDA approved a supplemental application for AUGMENTIN ES-600 by USAntibiotics, LLC, updating the product labeling.
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FDA approval · 2014-12-21FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for sulfamethoxazole and trimethoprim from Amneal Pharmaceuticals of New York LLC. The approval cove…
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CLINICAL_TRIALS trial_result · 2014-11-25Clinical Trial Update: inVENT-In-Office Study [NA]
The inVENT in-office study for Otitis Media has completed, and its results have been posted.
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CLINICAL_TRIALS trial_result · 2014-11-18Clinical Trial Update: Singapore Tympanostomy Tube Delivery System Study [NA]
Completed clinical trial of Integra LifeSciences' tympanostomy tube delivery system for Otitis Media; results were posted in 2014.
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CLINICAL_TRIALS trial_result · 2014-10-08Clinical Trial Update: A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children [Phase 4]
Pilot Phase 4 trial evaluating montelukast for treatment of acute otitis media in children has completed with results posted in 2014.
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FDA approval · 2014-09-26FDA 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. The supplement rel…
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CLINICAL_TRIALS trial_result · 2014-09-25Clinical Trial Update: Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion [NA]
A completed clinical trial evaluated the Acclarent Tympanostomy Tube Delivery System for patients requiring tympanostomy tube insertion in O…
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FDA label_change · 2014-09-22FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Northstar RxLLC)
The FDA approved a supplemental application for amoxicillin and clavulanate potassium filed by Northstar RxLLC, resulting in a label update …
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CLINICAL_TRIALS trial_result · 2014-09-19Clinical Trial Update: inVENT-visIOn Study [NA]
The inVENT-visIOn clinical trial evaluating a device for Otitis Media has completed, with results posted on 2014-09-19.
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CLINICAL_TRIALS trial_result · 2014-08-04Clinical Trial Update: Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus [NA]
A completed clinical trial evaluated lidocaine with epinephrine solution delivered via iontophoresis to the external auditory apparatus for …
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CLINICAL_TRIALS trial_result · 2014-07-28Clinical Trial Update: To Evaluate the Incidence of Acute Otitis Media in Children in Five East European Countries
A completed GlaxoSmithKline-sponsored trial evaluated the incidence of acute otitis media in children across five East European countries.
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CLINICAL_TRIALS trial_result · 2014-07-24Clinical Trial Update: Tympanostomy Tube Placement in Children in the Office (Inova Study) [NA]
This clinical trial update reports the completion of a study evaluating office-based tympanostomy tube placement in children for otitis medi…
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CLINICAL_TRIALS trial_result · 2014-07-22Clinical Trial Update: Homeopathic Ear Drops for Otitis Media Study [NA]
Completed clinical trial evaluating homeopathic ear drops for Otitis media; results were posted in 2014.
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CLINICAL_TRIALS trial_result · 2014-07-11Clinical Trial Update: Evaluation of the Tympanostomy Tube Delivery System [Phase 2, Phase 3]
A completed Phase 2/3 clinical trial evaluating a Tympanostomy Tube Delivery System for otitis media indications, with results posted in 201…
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CLINICAL_TRIALS trial_result · 2014-07-10Clinical Trial Update: PneuMum: Pneumococcal Vaccination of Australian Indigenous Mothers [Phase 3]
Phase 3 trial (PneuMum) investigating pneumococcal vaccination of Australian Indigenous mothers has completed.
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CLINICAL_TRIALS trial_result · 2014-04-01Clinical Trial Update: Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement [Phase 2, Phase 3]
A Phase 2/3 trial comparing dexmedetomidine to fentanyl for sedation/analgesia after pressure equalization tube placement, with results post…
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CLINICAL_TRIALS trial_result · 2014-03-21Clinical Trial Update: Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children [Phase 3]
Phase 3 trial update evaluating safety and immunogenicity of 10-valent and 13-valent pneumococcal conjugate vaccines in Papua New Guinean ch…
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CLINICAL_TRIALS trial_result · 2014-01-16Clinical Trial Update: Efficacy of KNT® (KINETUBE) in Recurrent Chronic Otitis Media in Children [NA]
Clinical trial update on the efficacy of KNT (KINETUBE) for recurrent chronic otitis media in children.
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CLINICAL_TRIALS trial_result · 2014-01-13Clinical Trial Update: Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Saudi Arabia
A completed GlaxoSmithKline-sponsored clinical trial in Saudi Arabia aimed to identify and characterize the bacteria causing acute otitis me…
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FDA label_change · 2013-12-06FDA Approved: CORTISPORIN TC — Supplemental Application (Endo USA, Inc.)
FDA announces a supplemental application for Cortisporin TC, a four-ingredient otic preparation (colistin sulfate, neomycin sulfate, thonzon…
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FDA approval · 2013-11-22FDA Approved: CEFIXIME — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for cefixime. This action updates the cefixime NDA, potentially expanding i…
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CLINICAL_TRIALS trial_result · 2013-09-04Clinical Trial Update: COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococcal Conjugate Vaccine [Phase 3]
Phase 3 COMPAS study evaluating Pneumococcal Conjugate Vaccine for pneumonia and acute otitis media; study completed with results posted in …