FDA accepts Dextenza NDA

The FDA has accepted a new drug application resubmission for Dextenza, according to an Ocular Therapeutix press release.
Dextenza (dexamethasone insert 0.4 mg) is a corticosteroid intracanalicular insert placed through the punctum to deliver dexamethasone for up to 30 days.
The NDA resubmission is considered by the FDA as a class 2 response to its complete response letter, which was issued in July 2017 and cited manufacturing deficiencies. A Prescription Drug User Fee Act date of Dec. 28 has been issued for the FDA’s review of the NDA, the release (Read more...)

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