Posted by Michael Wonder on 01 Oct 2019
Heron Therapeutics resubmits new drug application to FDA for HTX-011 for the management of post-operative pain
1 October 2019 - Heron Therapeutics today announced that it has resubmitted its new drug application to the U.S. FDA for HTX-011, an investigational agent for the management of postoperative pain.
The Company anticipates a 6 month review by the FDA.
The application for HTX-011 was resubmitted based on the outcome and final minutes of a Type A meeting with the FDA, which was conducted to obtain clarity on the Complete Response Letter (CRL) issued by the FDA in April 2019.
The CRL stated that the FDA was unable to approve the NDA in its present form based on the need for additional chemistry, manufacturing and controls and non-clinical information.
