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FDA accepts NDA resubmission for Dextenza

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The FDA has accepted a new drug application resubmission for Dextenza to treat ocular pain after ophthalmic surgery, according to a press release from Ocular Therapeutix.

Dextenza (dexamethasone insert) 0.4 mg for intracanalicular use is designed to deliver a tapered dexamethasone dose to the ocular surface for up to 30 days after ocular surgery.

The NDA resubmission was determined to be a complete response by the FDA, which designated it a Class 2 review, the release said. There is a target action date of July 19 under the Prescription Drug User Fee Act for potential approval of Dextenza.