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In some embodiments, therapeutically acceptable otic formulations are: The formulations disclosed herein alternatively encompass an otoprotectant agent in addition to the at least one active agent and/or excipients, including but not limited to such agents as antioxidants, alpha lipoic acid, calcium, fosfomycin or iron chelators, to counteract potential ototoxic effects that may arise from the use of specific therapeutic agents or excipients, diluents or carriers

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An FDA-approved drug is reviewed as a specific product with defined manufacturing controls, labeling, and evidence for approved uses