Aquestive Therapeutics has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate, Anaphylm (dibutepinephrine) sublingual film. This product is an orally-delivered epinephrine film for the treatment of severe allergic reactions, including anaphylaxis. The resubmission aims to address the deficiencies outlined in a Complete Response Letter (CRL) issued by the FDA earlier in the year.

Key Details

  • Event: The NDA for Anaphylm was officially resubmitted to the FDA on September 17, 2026.
  • Background: This action follows the company's receipt of a Complete Response Letter (CRL) from the FDA on January 30, 2026.
  • Pipeline Significance: Anaphylm is presented as a key growth driver with a potential peak annual revenue opportunity of over $1 billion.
  • Future Plans: The company plans to file for regulatory approval in Canada by the end of 2026 and in the European Union in the first quarter of 2027.