FDA accepts resubmission (NDA) of Dextenza (dexamethasone insert) 0.4 mg for intracanalicular use, for the treatment of ocular pain occurring after ophthalmic surgery.-Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. announced that the Company’s New Drug Application (NDA) resubmission for Dextenza (dexamethasone insert) 0.4 mg for intracanalicular use, for the treatment of ocular pain occurring after ophthalmic surgery has been accepted as a filing for review by the FDA. Dextenza is a product candidate administered by a physician as a bioresorbable intracanalicular insert and designed for drug release to the ocular surface for up to 30 days.
The FDA determined that the NDA resubmission is a complete response and designated the resubmission as a Class 2 review, with a target action date under the Prescription Drug User Fee Act (PDUFA) of July 19, 2017 for the potential approval of Dextenza.
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