HTX 011 has complete response letter from FDA for management of postoperative pain
Heron Therapeutics, Inc. announced that it received a Complete Response Letter (CRL) from the FDA on April 30, 2019 regarding its New Drug Application (NDA) for HTX-011 for the management of postoperative pain.
The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional CMC and non-clinical information. Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues, and there is no requirement for further clinical studies or data analyses.
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