Otitis Media
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-08-16FDA Approved: CLARITHROMYCIN — Supplemental Application (Sandoz Inc)
FDA approved Sandoz Inc's supplemental application for clarithromycin, marking a supplemental approval for this generic antibiotic. The acti…
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CLINICAL_TRIALS trial_result · 2022-12-14Clinical Trial Update: In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old [NA]
Completed in-office study of the Hummingbird device in children ages 6 months to 21 years for ear infection/otitis media; results posted in …
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CLINICAL_TRIALS trial_result · 2022-11-21Clinical Trial Update: Study of the Hummingbird TTS™ Tympanostomy Tube System
A completed clinical trial update for the Hummingbird TTS tympanostomy tube system in Otitis Media with results posted.
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FDA approval · 2022-11-02FDA Approved: AMOXICILLIN — Supplemental Application (USAntibiotics, LLC)
FDA approved a supplemental application for Amoxicillin submitted by USAntibiotics, LLC.
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FDA approval · 2022-11-02FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (USAntibiotics, LLC)
FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium submitted by USAntibiotics, LLC.
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FDA label_change · 2022-09-01FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Northstar RxLLC)
FDA approved a supplemental application for amoxicillin and clavulanate potassium submitted by Northstar RxLLC, resulting in updated labelin…
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CLINICAL_TRIALS trial_result · 2022-08-11Clinical Trial Update: Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children [Phase 4]
Phase 4 trial assessing how antimicrobial treatment for acute otitis media affects the intestinal microbiome in children.
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FDA approval · 2022-05-27FDA Approved: CIPROFLOXACIN AND DEXAMETHASONE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for ciprofloxacin and dexamethasone submitted by Sandoz Inc. The combination antibiotic/steroid is u…
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FDA approval · 2022-01-31FDA Approved: CLARITHROMYCIN — Original Application (Alembic Pharmaceuticals Inc.)
FDA approved Alembic Pharmaceuticals' generic clarithromycin under Original Application ANDA210459. This expands access to clarithromycin as…
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FDA approval · 2022-01-12FDA Approved: AZITHROMYCIN — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for AZITHROMYCIN submitted by Aurobindo Pharma Limited under an ANDA.
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CLINICAL_TRIALS trial_result · 2021-12-10Clinical Trial Update: Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media [NA]
Clinical trial update on tympanostomy tubes for children with recurrent acute otitis media; results have been posted after completion.
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CLINICAL_TRIALS trial_result · 2021-09-13Clinical Trial Update: Ketorolac Sublingual vs. Fentanyl Intranasal in Pain Control for Bilateral Myringotomy and Tubes (BMT) Placement in Children [Phase 4]
Phase 4 trial comparing ketorolac sublingual vs fentanyl intranasal for postoperative pain control in children undergoing bilateral myringot…
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CLINICAL_TRIALS trial_result · 2021-05-11Clinical Trial Update: Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil [NA]
Completed clinical trial assessing Lactobacillus rhamnosus GG for upper respiratory infection and acute otitis media; results posted in 2021…
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FDA approval · 2021-02-19FDA Approved: CEFDINIR — Original Application (American Health Packaging)
FDA approves the original ANDA for cefdinir (CEFDINIR) by American Health Packaging, making a generic cefdinir product available.
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CLINICAL_TRIALS trial_result · 2021-02-04Clinical Trial Update: Evaluation of Moderate to Severe Influenza Outcomes in Children
A completed clinical trial evaluating moderate to severe influenza outcomes in children with results posted in 2021, investigating influenza…
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CLINICAL_TRIALS trial_result · 2020-11-10Clinical Trial Update: Impact of Prevnar 13 on Ear Infections in Children
A completed clinical trial evaluating the impact of Prevnar 13 on ear infections in children, with results posted in 2020.
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FDA approval · 2020-11-03FDA Approved: CIPROFLOXACIN AND DEXAMETHASONE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for ciprofloxacin and dexamethasone, an otic antibiotic/steroid combination. The submission was file…
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CLINICAL_TRIALS trial_result · 2020-09-24Clinical Trial Update: Dose Ranging Study of OTO-201 in AOMT [Phase 2]
Phase 2 dose-ranging study of OTO-201 in Acute Otitis Media (AOM) and AOMT has completed with results posted.
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CLINICAL_TRIALS trial_result · 2020-09-23Clinical Trial Update: Open-Label Study of OTO-201 for Treatment of AOMT [Phase 2]
Open-label Phase 2 trial evaluating OTO-201 for Acute Otitis Media (AOM) and AOMT has completed with results posted in 2020.
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CLINICAL_TRIALS trial_result · 2020-09-22Clinical Trial Update: Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes [Phase 3]
Open-label Phase 3 trial in pediatric subjects with a history of otitis media requiring tympanostomy tubes completed with results posted.
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CLINICAL_TRIALS trial_result · 2020-09-03Clinical Trial Update: Evaluation of Cellphone Based Otoscopy in Pediatric Patients [NA]
A completed clinical trial evaluating cellphone-based otoscopy in pediatric patients with ear infection, including acute otitis media; resul…
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CLINICAL_TRIALS trial_result · 2020-08-11Clinical Trial Update: A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months [Phase 2]
Phase 2 trial completed evaluating OP0201 as adjunct treatment for acute otitis media in infants and young children; results posted in 2020.
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CLINICAL_TRIALS trial_result · 2020-08-10Clinical Trial Update: Improving Knowledge Translation Upon Emergency Department Discharge [Phase 3]
Phase 3 clinical trial assessing knowledge translation at emergency department discharge for otitis media; study completed.
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FDA approval · 2020-07-28FDA Approved: BACTRIM — Supplemental Application (Sun Pharmaceutical Industries, Inc)
FDA approved a supplemental application for BACTRIM (sulfamethoxazole and trimethoprim) filed by Sun Pharmaceutical Industries, Inc. to upda…
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CLINICAL_TRIALS trial_result · 2020-07-27Clinical Trial Update: Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A [Phase 3]
Phase 3 trial update on a GlaxoSmithKline pneumococcal conjugate vaccine (1024850A) reporting its immunogenicity, safety, and impact on carr…