DEXTENZA for ocular inflammation and pain following cataract surgery. CRL July 25 2016 due to manufacturing deficiencies and again in July 2017. NDA resubmitted with new PDUFA date December 28,
DEXTENZA for ocular inflammation and pain following cataract surgery. CRL July 25 2016 due to manufacturing deficiencies and again in July 2017. NDA resubmitted with new PDUFA date December 28, 2018.
|OCULAR THERAPEUTIX™ ANNOUNCES FDA ACCEPTANCE OF NDA RESUBMISSION FOR DEXTENZA®|
PDUFA date is set for December 28, 2018
BEDFORD, Mass.–(BUSINESS WIRE)–Jul. 19, 2018– Ocular Therapeutix™, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has received acknowledgement from the U.S. Food and Drug Administration (FDA) that the New Drug Application (NDA) for DEXTENZA® has been received. DEXTENZA (dexamethasone insert) 0.4mg is Ocular Therapeutix’s lead product candidate for the treatment of ocular pain following ophthalmic surgery. The FDA considers the NDA resubmission as a class 2 response to its July 2017 Complete Response Letter with a PDUFA (Prescription Drug User Fee Act) target date of December 28, 2018 for the completion of the FDA’s review of the DEXTENZA NDA.
“We are pleased with the recent news that the FDA has formally accepted our resubmission of the DEXTENZA NDA,” said Antony Mattessich, President and Chief Executive Officer. “This marks one more important step towards our goal of bringing this important new treatment to the market.”
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