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# Heron Resubmits NDA for Pain Drug
- URL: https://www.fdaweb.com/heron-resubmits-nda-for-pain-drug/
- Published: 2019-10-01T12:00:00.000Z
- Updated: 2026-09-15T01:53:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145143

Heron Therapeutics has resubmitted an NDA for HTX-011, an investigational agent for managing postoperative pain. The company expects a six-month review by the agency. The NDA was resubmitted based on feedback from an FDA/company meeting that sought clarity on an April complete response letter which requested additional chemistry, manufacturing and controls and non-clinical information.

HTX-011 is described by the company as a long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam. Heron says HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine solution in five surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty, and breast augmentation.