10:21 AM EDT, 07/02/2024 (MT Newswires) -- Heron Therapeutics ( HRTX ) said Tuesday the US Food and Drug Administration acknowledged the receipt of its prior approval supplement application for Zynrelef extended-release solution vial access needle.

The firm said the FDA has assigned a prescription drug user fee act goal date of Sept. 23, by which the regulator must respond.

If approved, the launch of the vial access needle will replace the vented vial spike and may simplify aseptic preparation, Heron said, adding it will also cut Zynrelef's withdrawal time to between 20 and 45 seconds from up to three minutes.

The vial access needle is expected to be available in Q4, if approved by the regulator, Heron said.

Zynrelef, which is used for postoperative pain, delivers a combination of the local anesthetic bupivacaine and nonsteroidal anti-inflammatory drug meloxicam, the company said.

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