Posted by Michael Wonder on 01 Apr 2019
U.S. FDA acknowledges receipt of Intellipharmaceutics' resubmission of oxycodone ER new drug application, deems it a complete response, and designates 28 August 2019 as goal date for review
29 March 2019 - Intellipharmaceutics announced today that the U.S. FDA has acknowledged receipt of its resubmission of the Oxycodone ER new drug application filed on February 28, 2019.
The FDA has informed the company that it considers the resubmission a complete response to the September 22, 2017 action letter it issued in respect of the application. The FDA has also assigned a Prescription Drug User Fee Act goal date of August 28, 2019.
Read Intellipharmaceuticals press release
