Aquestive Therapeutics (AQST) announced that the FDA has informed the company that an advisory committee meeting is not required for Anaphylm or dibutepinephrine Sublingual Film. The PDUFA target action date for Anaphylm remains January 31, 2026.
Dan Barber, President and CEO of Aquestive Therapeutics, said: "If approved by the FDA, we believe Anaphylm would mark a meaningful advancement in anaphylaxis treatment. We are well-positioned for launch and, based on our recent $160 million in financing activities, we will have the ability to ensure broad outreach to healthcare providers, caregivers, and patients following FDA approval."
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