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February 3, 2026

Aquestive receives FDA CRL for Anaphylm allergic reaction treatment

Aquestive Therapeutics has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its new drug application (NDA) for Anaphylm, a sublingual film formulation of dibutepinephrine.

Aquestive receives FDA CRL for Anaphylm allergic reaction treatment