FDA accepts Aquestive Therapeutics’ Anaphylm NDA resubmission
The FDA set a PDUFA goal date of March 16, 2027.
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11:04:52 AM UTC
SquawkNews
Aquestive Therapeutics said the FDA accepted its Anaphylm (dibutepinephrine) NDA resubmission as complete and set a Class 2 PDUFA goal date of March 16, 2027.Material DetailsContext by AI AnalystThis is a mid-cycle regulatory step following a Complete Response Letter earlier in 2026 and subsequent…