Ocular Therapeutix (NSDQ:OCUL) said today that the FDA rejected its resubmission of a new drug application for Dextenza.
This is the second time that Ocular has received the FDA’s dreaded complete response letter for Dextenza. In July last year, the FDA denied approval for Ocular’s hydrogel plug after it discovered ‘deficiencies in manufacturing process and controls’ in a pre-new drug application approval inspection.
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