Aquestive Therapeutics (AQST) said Monday it has received "positive feedback" from the US Food and Drug Administration leading up to the company's planned New Drug Application submission for Anaphylm Sublingual Film to treat severe allergic reactions, including anaphylaxis.
Aquestive said the FDA wrote in a written response it agreed with the pharmaceutical company's planned NDA content and format, which includes the NDA submission, safety evaluation, and a pediatric trial. The company said it has begun the trial of its oral form of delivering epinephrine at both of its US and Canadian sites.
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