AQST PDUFA Date: Anaphylm Page updated November 5, 2026 · next FDA decision on the calendar · Data as of Nov 5, 2026 5:03 AM ET FDA decision (PDUFA) target Mar 16, 2027 · Aquestive Therapeutics, Inc. · Anaphylaxis (Class 2 resubmission after the January 30, 2026 CRL)
Key facts FDA PDUFA target date 2027-03-16
Drug / candidate Anaphylm (dibutepinephrine)
Indication Anaphylaxis (Class 2 resubmission after the January 30, 2026 CRL)
Company Aquestive Therapeutics, Inc.
Market-cap tier Small
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See every 2027 PDUFA date → All March 2027 PDUFA dates → FAQ When is the AQST PDUFA date? The FDA PDUFA target date for AQST (Aquestive Therapeutics, Inc.) is 2027-03-16 for Anaphylm (dibutepinephrine). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is AQST's drug Anaphylm? Anaphylm (dibutepinephrine) is Aquestive Therapeutics, Inc.'s candidate under FDA review for Anaphylaxis (Class 2 resubmission after the January 30, 2026 CRL).
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