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ARTICLE | Company News

Heron's non-opioid HTX-011 gets Priority Review

December 31, 2018 10:04 PM UTC

FDA accepted and granted Priority Review to an NDA for HTX-011 from Heron Therapeutics Inc. (NASDAQ:HRTX) for postoperative pain management. The PDUFA date is April 30.

Heron said FDA indicated that it has no plans to hold an advisory committee meeting for the non-opioid therapy. HTX-011 is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam using Heron's Biochronomer polymer-based drug delivery platform...