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FDA raises concerns about manufacturing deficiencies in Dextenza complete response letter
Ocular Therapeutix received a complete response letter from the FDA regarding the new drug application for Dextenza for the treatment of postoperative ocular pain, according to a press release. The letter addresses the FDA’s concerns about the deficiencies in the manufacturing process and controls that were identified during a pre-NDA approval inspection of the company’s manufacturing facility, but the FDA did not provide details on which manufacturing deficiencies were identified.