Otitis Media
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2011-06-08Clinical Trial Update: A Study of the Effectiness and Safety of Levofloxacin in Treating Children With a Rapid and Severe Onset of Infection and Inflammation of the Middle Ear That is Difficult to Treat [Phase 3]
Phase 3 clinical trial evaluating the effectiveness and safety of levofloxacin in treating children with complicated otitis media; the study…
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CLINICAL_TRIALS trial_result · 2011-05-17Clinical Trial Update: A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections [Phase 3]
Phase 3 trial comparing a single high-dose azithromycin extended-release regimen with 10 days of high-dose amoxicillin-clavulanate in childr…
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CLINICAL_TRIALS trial_result · 2011-05-17Clinical Trial Update: Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media [Phase 3]
Phase 3 study comparing pediatric versus adult concentration of Zmax (azithromycin extended-release) for acute otitis media has completed.
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FDA approval · 2011-05-04FDA Approved: CEPHALEXIN — Supplemental Application (AvKARE)
FDA approved a supplemental application for Cephalexin from AvKARE under ANDA 062713, authorizing continued manufacture and marketing of a C…
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CLINICAL_TRIALS trial_result · 2011-03-04Clinical Trial Update: Prophylactic Efficacy of Relenza Against Influenza A and B
Completed clinical trial results evaluating whether Relenza (zanamivir) can prevent influenza A and B infections.
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FDA approval · 2011-02-22FDA Approved: CEPHALEXIN — Supplemental Application (AVKARE)
The FDA approved a supplemental application for Cephalexin from AvKare.
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FDA approval · 2011-01-27FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for amoxicillin and clavulanate potassium (Hikma Pharmaceuticals USA Inc.), updating the product…
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CLINICAL_TRIALS trial_result · 2011-01-10Clinical Trial Update: Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media [Phase 3]
A Phase 3 clinical trial evaluating levofloxacin for recurrent and/or persistent acute otitis media in children has completed.
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FDA approval · 2010-12-22FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for clarithromycin by Sandoz Inc., confirming the approval of a generic clarithromycin product under…
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FDA approval · 2010-12-20FDA Approved: CEPHALEXIN — Original Application (AvPAK)
FDA approved the original application for Cephalexin (generic) from AvPAK under ANDA090836.
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CLINICAL_TRIALS trial_result · 2010-12-20Clinical Trial Update: Pneumococcal Vaccination of Otitis-prone Children [NA]
The clinical trial assessing pneumococcal vaccination in otitis-prone children with recurrent acute otitis media has completed.
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CLINICAL_TRIALS trial_result · 2010-12-02Clinical Trial Update: Ear Drops for Children With Otitis Media [NA]
This clinical trial update notes the completion of a study on ear drops for children with Acute Otitis Media; the trial results were posted …
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CLINICAL_TRIALS trial_result · 2010-08-11Clinical Trial Update: Acute Otitis Media (AOM) Therapy Trial in Young Children [Phase 4]
This document reports the completion and posting of results for a Phase 4 trial evaluating therapy for acute otitis media in young children.
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CLINICAL_TRIALS research · 2010-07-07Clinical Trial Update: Bacterial Assessment of Middle Ear Fluid in Children Undergoing Ventilation Tube Placement Surgery
Clinical trial update examining the bacterial assessment of middle ear fluid in children undergoing ventilation tube placement.
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CLINICAL_TRIALS trial_result · 2010-06-29Clinical Trial Update: Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media
A completed clinical trial investigated Streptococcus pneumoniae presence in the noses and throats of infants with acute otitis media.
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FDA approval · 2010-06-07FDA Approved: CEFUROXIME AXETIL — Original Application (Golden State Medical Supply, Inc.)
FDA approved an original application for cefuroxime axetil from Golden State Medical Supply, Inc. for use as an oral antibiotic (ANDA).
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CLINICAL_TRIALS research · 2010-05-24Clinical Trial Update: Study to Identify and Characterize Bacteria Causing Acute Otitis Media in South African Children
A completed clinical trial sponsored by GlaxoSmithKline to identify and characterize bacteria causing acute otitis media in South African ch…
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CLINICAL_TRIALS trial_result · 2010-05-24Clinical Trial Update: Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children [Phase 4]
Phase 4 trial evaluating long-term antibiotics for treatment and prevention of otitis media in Aboriginal children has completed.
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FDA label_change · 2010-04-27FDA Approved: CEFACLOR — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for Cefaclor by Teva, updating the product labeling.
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FDA approval · 2010-02-16FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Original Application (Rising Pharma Holdings, Inc.)
FDA approved Rising Pharma Holdings, Inc.'s generic product Sulfamethoxazole and Trimethoprim as an Original Application (ANDA).
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CLINICAL_TRIALS trial_result · 2010-01-25Clinical Trial Update: Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media [Phase 2]
Phase 2 clinical trial update comparing pharmacokinetics of immediate-release and extended-release azithromycin in children with acute otiti…
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CLINICAL_TRIALS trial_result · 2009-10-02Clinical Trial Update: Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media [Phase 3]
The document reports the completion of a Phase 3 Japanese study evaluating telithromycin for acute otitis media in children.
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FDA approval · 2009-05-14FDA Approved: CEFDINIR — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for CEFDINIR (cefdinir) submitted by Sandoz Inc.
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CLINICAL_TRIALS trial_result · 2009-04-03Clinical Trial Update: TELI COM - Telithromycin in Children With Otitis Media [Phase 3]
A Phase 3 trial of telithromycin in children with otitis media has been terminated.
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CLINICAL_TRIALS trial_result · 2009-04-03Clinical Trial Update: Comparative Study to Evaluate the Efficacy and Safety of Telithromycin Given Once Daily Versus Cefuroxime Axetil Given Twice Daily in Children With Middle Ear Infections [Phase 3]
Phase 3 comparative trial evaluating Telithromycin once daily versus Cefuroxime axetil twice daily in children with otitis media; the study …