Aquestive resubmits FDA NDA for Anaphylm after human factors, confirmatory PK studies

By Public Technologies
  • Aquestive Therapeutics resubmitted its FDA application for Anaphylm (dibutepinephrine) sublingual film to treat severe allergic reactions, including anaphylaxis.
  • The filing is backed by positive topline human factors and confirmatory PK study results already disclosed in August 2026.
  • Studies supported a revised package and instructions, showing easier, faster use with no protocol-defined self-administration errors.
  • FDA will classify the resubmission, setting the review timeline and next decision point for a potential US launch.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Aquestive Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202609170700PRIMZONEFULLFEED9828235) on September 17, 2026, and is solely responsible for the information contained therein.

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