Posted by Michael Wonder on 19 Jul 2018
Ocular Therapeutix announces FDA acceptance of NDA resubmission for Dextenza
19 July 2018 - PDUFA date is set for 28 December 2018.
Ocular Therapeutix today announced that it has received acknowledgement from the U.S. FDA that the new drug application 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 target date of 28 December 2018 for the completion of the FDA’s review of the Dextenza application.
