Ocular Therapeutix (NSDQ:OCUL) said today that it submitted details of a manufacturing equipment change as an amendment to the new drug application resubmission for Dextenza, the company’s dexamethasone insert that is currently under review by the FDA.
The FDA is slated to make a decision about the product’s regulatory approval by July 19. But the company recently revealed that the FDA issued a Form 483 to Ocular following a pre-approval inspection of a manufacturing facility, which detailed a number of issues relating to the manufacture of Dextenza.
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