FDA approves new drug application for TobraDex ST
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The U.S. Food and Drug Administration has approved Alcon's new drug application for a new formulation of a fixed combination of tobramycin and dexamethasone for treating inflammatory ocular conditions.
The application provides for the use of the drug, called TobraDex ST (tobramycin/dexamethasone ophthalmic suspension 0.3%/0.05%), for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and for instances in which there is significant risk of superficial bacterial ocular infection, according to a letter from the FDA.
Currently, Alcon has not disclosed its plans to market the drug.