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Aquestive Therapeutics Announces Completion of Type A Meeting with FDA for Anaphylm™ (dibutepinephrine) Sublingual Film

Aquestive Therapeutics (AQST)Aquestive TherapeuticsFDA / regulatory

Reaffirms guidance to resubmit the Anaphylm NDA in Q3 2026 Received clarifying feedback from the FDA on pharmacokinetic (PK) and human factor (HF) study designs Final FDA meeting minutes expected by early May 2026 WARREN, N.J., March 30, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc.

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Aquestive Therapeutics

Oral Film Drug Delivery Company Aquestive Therapeutics develops medicines using proprietary film-based delivery technologies for allergic reactions and other conditions. Anaphylm Anaphylm is a postage-stamp-sized sublingual film containing a prodrug of epinephrine for severe allergic reactions, including anaphylaxis. It dissolves without...

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