Aquestive Therapeutics announced the resubmission of its New Drug Application to the U.S. Food and Drug Administration for Anaphylm, a sublingual film for treating Type I allergic reactions including anaphylaxis. The resubmission addresses deficiencies from a January 2026 Complete Response Letter by incorporating revised packaging that reduced median pouch-opening time from 17 seconds to 3 seconds and confirmed pharmacokinetic data in healthy volunteers. No protocol-defined use errors were observed during self-administration studies supporting the filing. Aquestive Therapeutics is a pharmaceutical company advancing medicines through innovative oral film delivery technologies.
