RegulatoryCompany release

FDA accepts Aquestive's Anaphylm resubmission, sets 16 March 2027 PDUFA date

🇺🇸 Aquestive Therapeutics, Inc. (AQST) · Thu 05 Nov 2026

The agency has accepted a Class 2 resubmission for the sublingual epinephrine film after a January 2026 Complete Response Letter, according to the company's November 2026 presentation.

Aquestive Therapeutics has said the US Food and Drug Administration accepted its Class 2 resubmission of the new drug application for Anaphylm (dibutepinephrine) sublingual film. The product is an oral epinephrine treatment. The company set out the update in a corporate presentation dated November 2026.

The resubmission 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 application. The summary of the presentation does not give the reasons for the earlier rejection or describe what the resubmission changed.

Aquestive also outlined plans for filings in Canada and the European Union for Anaphylm, though no timelines were provided in the material available. Beyond Anaphylm, the presentation covered AQST-108, an epinephrine topical gel being developed for atopic dermatitis, and Libervant (diazepam) buccal film, which is partnered with Eton.

As general context, a Class 2 resubmission is the category the FDA uses for resubmissions after a complete response that typically carry a six-month review goal, and a PDUFA date is the target date for the agency to complete its review.

What it means for your team

  • Regulatory teams tracking epinephrine alternatives to injectors should note 16 March 2027 as the next decision point for Anaphylm in the US.
  • Details of the January 2026 Complete Response Letter and how it was addressed are not in the available material, so the approval outlook cannot be assessed from this update.
  • Canadian and EU filing plans signal possible future submissions to Health Canada and the EMA, but no dates have been disclosed.
  • Market-access teams should treat the company's pipeline items, including AQST-108 and Libervant, as company-reported plans rather than regulatory outcomes.

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.

More Regulatory All →