Otitis Externa
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Sign up freeTop drugs studied for this disease
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FDA approval · 2018-04-11FDA Approved: FLAC OTIC OIL — Original Application (Patrin Pharma, Inc.)
The FDA approved Patrin Pharma's original ANDA for FLAC OTIC OIL, a fluocinolone acetonide otic corticosteroid product intended to treat inf…
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FDA approval · 2017-12-19FDA Approved: NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension from Rising Pharma Hold…
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FDA approval · 2017-03-20FDA Approved: CIPRO HC — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for CIPRO HC (ciprofloxacin hydrochloride and hydrocortisone) submitted by Sandoz Inc.
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CLINICAL_TRIALS trial_result · 2016-10-18Clinical Trial Update: A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa [Phase 3]
Phase 3 bioequivalence study comparing two ciprofloxacin/dexamethasone otic formulations for otitis externa was terminated.
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CLINICAL_TRIALS trial_result · 2016-04-20Clinical Trial Update: Topical Voltaren in Otitis Externa [Phase 2]
Phase 2 trial of topical diclofenac (Voltaren) for otitis externa was terminated.
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FDA approval · 2016-03-29FDA Approved: CORTISPORIN TC — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for Cortisporin TC, a four-ingredient otic preparation, under Endo USA, Inc.
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CLINICAL_TRIALS trial_result · 2015-04-17Clinical Trial Update: A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension [Phase 3]
Phase 3 trial update comparing two formulations of ciprofloxacin hydrochloride + hydrocortisone otic suspension for otitis externa.
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CLINICAL_TRIALS trial_result · 2014-06-18Clinical Trial Update: Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa [Phase 3]
Phase 3 trial evaluating the safety and efficacy of AL-60371 Otic Suspension 0.3% for acute otitis externa; the study completed and results …
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CLINICAL_TRIALS trial_result · 2013-12-10Clinical Trial Update: A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis [Phase 2]
Phase 2 study of DPK-060 in acute otitis externa was completed to evaluate safety and efficacy, with results posted in 2013.
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CLINICAL_TRIALS trial_result · 2013-12-10Clinical Trial Update: Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa [Phase 3]
A Phase 3 study evaluated the safety and efficacy of AL-60371 0.3% topical otic suspension for acute otitis externa, with results posted in …
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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 label_change · 2013-07-09FDA Approved: CIPRO HC — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for CIPRO HC (ciprofloxacin hydrochloride and hydrocortisone) from Sandoz Inc, resulting in upda…
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CLINICAL_TRIALS trial_result · 2013-07-09Clinical Trial Update: Study of Ear Comfort Ear Drops to Treat AOE Cases Compared to DexOtic & Otidin(R) [Phase 2]
This is a Phase 2 clinical trial update comparing Ear Comfort Ear Drops with DexOtic and Otidin for Acute Otitis Externa; the current status…
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FDA approval · 2013-05-22FDA Approved: CIPROFLOXACIN AND DEXAMETHASONE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for ciprofloxacin and dexamethasone (Ciprodex) from Sandoz Inc, expanding the product label.
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CLINICAL_TRIALS trial_result · 2012-12-03Clinical Trial Update: A Phase III Study of an Otic Formulation in Acute Otitis Externa [Phase 3]
Alcon Research reports completion of a Phase III trial evaluating an otic formulation for Acute Otitis Externa.
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CLINICAL_TRIALS trial_result · 2011-11-02Clinical Trial Update: Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa [Phase 2]
Phase 2 trial comparing once-daily Ciprodexa Otic Foam to twice-daily Ciprodex Ear Drops in acute otitis externa completed, reporting effica…
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CLINICAL_TRIALS trial_result · 2011-03-15Clinical Trial Update: Safety and Efficacy of Once-Daily Dosing of FoamOtic Cipro Compared to Twice-Daily Dosing of Ciloxan Ear Drops in Patients With Acute External Otitis [Phase 2]
A Phase 2 trial compares once-daily FoamOtic Cipro to twice-daily Ciloxan ear drops for acute external otitis, reporting safety and efficacy…
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CLINICAL_TRIALS trial_result · 2009-12-24Clinical Trial Update: Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa [Phase 1, Phase 2]
A completed Phase 1/Phase 2 trial comparing Foam Otic Cipro with Ciloxan (ciprofloxacin) solution for acute otitis externa to assess safety …
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CLINICAL_TRIALS research · 2009-08-27Clinical Trial Update: Phase III Open Study, Prospective, Multicenter, Randomized, Comparative to the Positive Control for Evaluating the Efficacy and Safety of Auris-Sedina in the Symptomatic Control of Otalgy in Patients With or Without Acute External Otitis. [Phase 3]
Open Phase 3 clinical trial evaluating the efficacy and safety of Auris-Sedina for symptomatic relief of otalgia in patients with or without…
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FDA approval · 2008-08-06FDA Approved: OFLOXACIN OTIC — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for OFLOXACIN OTIC from Apotex Corp., updating the product's labeling and/or approval scope.
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FDA approval · 2007-09-28FDA Approved: OFLOXACIN OTIC — Original Application (Apotex Corp.)
FDA approved Apotex Corp's generic OFLOXACIN OTIC as an original ANDA.
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FDA approval · 2006-07-03FDA Approved: NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE — Supplemental Application (Bausch & Lomb Incoporated)
The FDA approved a supplemental application from Bausch & Lomb for Neomycin and Polymyxin B Sulates and Hydrocortisone, signaling an update …