Posted by Michael Wonder on 30 Jun 2020
Heron Therapeutics receives complete response letter for HTX-011 for the management of post-operative pain
29 June 2020 - Complete response letter requests additional non-clinical information.
Heron Therapeutics today announced that it received a complete response letter from the U.S. FDA on 26 June 2020 regarding its new drug application for HTX-011 for the management of post-operative pain.
Based on the complete review of the application, the FDA did not identify any clinical safety or efficacy issues or chemistry, manufacturing and controls issues.
