Posted by Michael Wonder on 12 Jul 2017
Ocular Therapeutix receives complete response letter from FDA for Dextenza NDA
11 July 2017 - No efficacy or safety issues raised by FDA.
Ocular Therapeutix announced today that it received a complete response letter from the U.S. FDA, regarding its resubmission of a new drug application for Dextenza (dexamethasone insert) 0.4 mg for the treatment of ocular pain following ophthalmic surgery.
The CRL states that the FDA has determined that it cannot approve the application in its present form.
