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# Heron Resubmits HTX-011 Pain Drug NDA
- URL: https://www.fdaweb.com/heron-resubmits-htx-011-pain-drug-nda/
- Published: 2020-11-13T12:00:00.000Z
- Updated: 2026-09-14T16:36:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148083

Heron Therapeutics has resubmitted to FDA its NDA for HTX-011, an investigational agent for managing postoperative pain. A company [statement](https://www.marketwatch.com/press-release/heron-therapeutics-resubmits-new-drug-application-to-fda-for-htx-011-for-the-treatment-of-postoperative-pain-2020-11-13?tesla=y&ref=fdaweb.com) says the NDA was resubmitted based on the outcome and final minutes of a September Type A end-of-review meeting with the agency that discussed what was needed to address the complete response letter the firm received in June.

The company says the letter asked for information on four non-clinical issues and that it has addressed the issues.

HTX-011 is described as an investigational non-opioid analgesic that is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam.