FDA Says No Advisory Committee Meeting Needed For Aquestive’s Oral Epinephrine Film
Synopsis
The FDA is expected to decide on Aquestive’s application for approval of the sublingual film by January 31, 2026.
Aquestive Therapeutics (AQST) on Thursday said that the U.S. Food and Drug Administration has informed the company that an advisory committee meeting is not required for Anaphylm Sublingual Film.
Anaphylm Sublingual Film is a polymer matrix-based epinephrine prodrug product candidate. It is similar in size to a postage stamp and begins to dissolve on contact. No water or swallowing is required for administration.
According to Aquestive, Anaphylm has the potential to be the first and only orally delivered epinephrine product for the treatment of severe allergic reactions in the U.S. The FDA is expected to decide on Aquestive’s application for approval of the sublingual film by January 31, 2026.
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