08:35 AM EDT, 05/29/2024 (MT Newswires) -- Heron Therapeutics ( HRTX ) said Wednesday it submitted the prior approval supplement to the US Food and Drug Administration for Zynrelef's extended-release solution Vial Access Needle.
The company is seeking approval for the new Zynrelef kit, which could simplify preparation and reduce the drug's withdrawal time to 20 to 45 seconds from the current three minutes.
Heron said it expects to receive the assigned action date for the FDA's review within the next several weeks and anticipates an action date between four and six months.
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