Otitis Externa
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS research · 2026-04-21Clinical Trial Update: Nigella Sativa Oil for Eczematous Otitis Externa [NA]
A clinical trial is recruiting to evaluate Nigella Sativa Oil for eczematous otitis externa.
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CLINICAL_TRIALS research · 2026-01-30Clinical Trial Update: Non Interventional Clinical Investigation of Ectoin Ear Spray in Skin Treatment of Outer Ear Canal Irritations
A completed non-interventional clinical study evaluated Ectoin Ear Spray for outer ear canal irritations, including pruritus, dermatitis, an…
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FDA approval · 2026-01-06FDA Approved: CIPROFLOXACIN AND DEXAMETHASONE — Original Application (Upsher-Smith Laboratories, LLC)
FDA approved Ciprofloxacin hydrochloride and dexamethasone under an original application from Upsher-Smith Laboratories, for otic use to tre…
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FDA approval · 2025-09-26FDA Approved: CLOTIC (CLOTRIMAZOLE) OTIC SOLUTION — Original Application (Carwin Pharmaceutical Associates, LLC)
The FDA approved CLOTIC, a clotrimazole otic solution, under an original NDA from Carwin Pharmaceutical Associates for the treatment of fung…
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FDA approval · 2025-07-09FDA Approved: CIPROFLOXACIN AND DEXAMETHASONE — Supplemental Application (Dr. Reddy's Laboratories, Inc.)
The FDA approved a supplemental application for Ciprofloxacin and Dexamethasone from Dr. Reddy's Laboratories, granting regulatory approval …
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FDA approval · 2024-12-03FDA Approved: HYDROCORTISONE AND ACETIC ACID — Supplemental Application (Saptalis Pharmaceuticals, LLC)
The FDA approved a supplemental application for Hydrocortisone and Acetic Acid Otic from Saptalis Pharmaceuticals, LLC. This action authoriz…
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CLINICAL_TRIALS trial_result · 2024-11-15Clinical Trial Update: Performance and Safety of Otinova® Ear Spray [NA]
A clinical trial evaluating Otinova Ear Spray for otitis externa was terminated, and results have been posted.
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FDA approval · 2024-11-05FDA Approved: CIPROFLOXACIN OTIC — Original Application (Genus Lifesciences)
FDA approved Ciprofloxacin Otic under Genus Lifesciences' original application as a generic antibiotic ear drop for otitis externa.
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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 · 2022-07-14FDA Approved: OFLOXACIN — Original Application (Lifestar Pharma LLC)
FDA approved the original application for OFLOXACIN OTIC from Lifestar Pharma LLC under ANDA 216130.
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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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CLINICAL_TRIALS trial_result · 2021-06-14Clinical Trial Update: FST-201 in the Treatment of Acute Otitis Externa [Phase 3]
Phase 3 clinical trial update for FST-201 in acute otitis externa has completed.
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CLINICAL_TRIALS trial_result · 2021-05-28Clinical Trial Update: Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa [Phase 3]
Phase 3 trial comparing ciprofloxacin 0.3% with dexamethasone 0.1% for acute otitis externa; results completed with results posted.
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CLINICAL_TRIALS trial_result · 2021-05-27Clinical Trial Update: FST-201 In The Treatment of Acute Otitis Externa [Phase 3]
Phase 3 trial of FST-201 for acute otitis externa was terminated.
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CLINICAL_TRIALS trial_result · 2021-04-09Clinical Trial Update: Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa [Phase 3]
Phase 3 trial results for DF289 plus DF277 otic solution in acute otitis externa have been completed with results posted.
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CLINICAL_TRIALS trial_result · 2020-11-19Clinical Trial Update: A Phase III Study of Ciprofloxacin Plus Fluocinolone in Acute Otitis Externa (AOE) [Phase 3]
A Phase III trial of ciprofloxacin plus fluocinolone for acute otitis externa is in progress with status not disclosed.
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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 · 2020-09-22Clinical Trial Update: OTO-201 for the Treatment of Otitis Externa [Phase 2]
Phase 2 clinical trial update for OTO-201 in Otitis Externa has completed with results posted.
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CLINICAL_TRIALS trial_result · 2020-09-22Clinical Trial Update: Phase 3 Study of OTO-201 in Acute Otitis Externa [Phase 3]
Phase 3 trial of OTO-201 in Acute Otitis Externa (Swimmer's Ear) completed; results posted in 2020.
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FDA approval · 2020-08-10FDA Approved: CIPROFLOXACIN AND DEXAMETHASONE — Original Application (Dr. Reddy's Laboratories, Inc.)
FDA approves the original application for ciprofloxacin and dexamethasone by Dr. Reddy's Laboratories as a generic product.
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FDA approval · 2019-08-30FDA Approved: OFLOXACIN — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal’s generic Ofloxacin Otic (OFLOXACIN OTIC) under an Original Application for the treatment of otitis externa.
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FDA approval · 2019-03-15FDA Approved: NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION — Supplemental Application (Rising Pharma Holdings, Inc.)
FDA approved a supplemental application for Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension from Rising Pharma Holdings…
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FDA approval · 2019-02-21FDA Approved: CIPROFLOXACIN AND DEXAMETHASONE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for ciprofloxacin and dexamethasone from Sandoz, updating the approval status for this otic suspensi…
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FDA approval · 2019-01-05FDA Approved: CORTISPORIN TC — Supplemental Application (Endo USA, Inc.)
The FDA approved a supplemental application for Cortisporin TC (colistin sulfate, neomycin sulfate, thonzonium bromide, and hydrocortisone a…
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CLINICAL_TRIALS trial_result · 2018-07-13Clinical Trial Update: Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto) [NA]
Clinical trial update for the PED-Oto smartphone otoscope study conducted by Emory University; the trial status is completed and results wer…