RegulatoryCompany release

Aquestive resubmits Anaphylm NDA; FDA sets March 2027 decision date after rejection

🇺🇸 Aquestive Therapeutics, Inc. (AQST) · Tue 03 Nov 2026

The company has refiled its epinephrine prodrug sublingual film application with the FDA following January's Complete Response Letter, and plans a Health Canada submission in the fourth quarter.

Aquestive Therapeutics has resubmitted its new drug application for Anaphylm (dibutepinephrine) sublingual film to the US Food and Drug Administration, the company said in its third-quarter 2026 earnings materials dated 3 November. The product is intended for severe allergic reactions, including anaphylaxis.

The refiling follows a Complete Response Letter that the FDA issued on 30 January 2026. The agency has now assigned a PDUFA goal date of 16 March 2027 for its decision on the resubmitted application.

Aquestive also plans to file for Anaphylm with Health Canada in the fourth quarter of 2026, according to the materials. The summary available does not specify the contents of the resubmission or the reasons behind the earlier rejection, and the full source text was not available for this report.

Separately, the company said that in October it out-licensed Libervant to Eton Pharmaceuticals. The terms include $10 million upfront, up to $47.5 million in milestone payments and royalties in the mid-teens.

What it means for your team

  • The FDA decision date of 16 March 2027 gives regulatory teams a fixed milestone for tracking the first sublingual-film epinephrine option for anaphylaxis from this sponsor.
  • A planned Health Canada filing in Q4 2026 signals that Aquestive intends to pursue a second major market in parallel with the US review.
  • Market-access teams should note that any launch timing depends on the FDA outcome; the company's disclosures here do not detail the issues raised in the January Complete Response Letter.

Company's press release (SEC filing): Aquestive Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Aquestive Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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