Posted by Michael Wonder on 13 Nov 2020
Heron Therapeutics resubmits new drug application to FDA for HTX-011 for the treatment of post-operative pain
13 November 2020 - Heron Therapeutics today announced that the new drug application was resubmitted to the U.S. FDA for HTX-011, an investigational agent for the management of postoperative pain.
The new drug application for HTX-011 was resubmitted based on the outcome and final minutes of a Type A End-of-Review meeting with the FDA in September, which was conducted to obtain clarity on the information needed to address the complete response letter issued by the FDA in June 2020.
