newsfilter
← Latest News
GlobeNewswire·

Aquestive Therapeutics Announces FDA Acceptance of Anaphylm™ NDA Resubmission and PDUFA Goal Date of March 16, 2027

AQST
  • FDA accepted Aquestive's resubmission of the New Drug Application for Anaphylm as complete & classified it as a Class 2 response.
  • The Prescription Drug User Fee Act (PDUFA) goal action date is set for March 16, 2027.
  • Aquestive plans to submit its New Drug Submission to Health Canada for Anaphylm in Q4 2026.
  • The resubmission followed positive human factors & pharmacokinetic study results submitted on September 16, 2026.
  • Anaphylm is a sublingual film designed to be the first oral rescue medication for severe allergic reactions if approved.
  • The product is smaller than a credit card, requires no water for administration, & is designed to withstand weather exposure.
  • Aquestive is advancing commercial preparations to enable a potential launch upon FDA approval.