(RTTNews) - Aquestive Therapeutics (AQST) announced that it has resubmitted its New Drug Application to the FDA for Anaphylm sublingual film for the treatment of Type I allergic reactions, including anaphylaxis. The company said the resubmission is supported by positive topline human factors and pharmacokinetic study results announced in August 2026. The original NDA for Anaphylm was submitted in March 2025. The FDA issued a Complete Response Letter on January 30, 2026. In response to the CRL, Aquestive completed a human factors study evaluating revised packaging that incorporated modifications to the pouch opening, instructions for use, and pouch and carton labeling.
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