Aquestive Therapeutics Announces FDA Acceptance of Anaphylm™ NDA Resubmission and PDUFA Goal Date of March 16, 2027
The FDA accepted Aquestive's resubmission of the Anaphylm NDA as complete and assigned a Class 2 PDUFA goal date of March 16, 2027. The resubmission, filed September 16, 2026, followed positive human factors and pharmacokinetic study results addressing the FDA's January 30, 2026 Complete Response Letter.
Key figures
- Drug Name
- Anaphylm (dibutepinephrine) sublingual film
- Phase Of Trial
- NDA resubmission (Class 2)
- Crl date
- January 30, 2026
- Pdufa date
- March 16, 2027
- Health canada nds
- Q4 2026
- Resubmission date
- September 16, 2026
AI analysis
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