Aquestive Therapeutics announces regulatory development for Anaphylm (dibutepinephrine) sublingual film

Aquestive Therapeutics

9 January 2026 - Announces receipt of FDA letter stating it has identified deficiencies that preclude labeling discussions for Anaphylm at this time.

Aquestive Therapeutics today provided an update on the regulatory approval of Anaphylm and its business.

Read Aquestive Therapeutics press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier , Registration