FDA Accepts Aquestive Resubmission for Anaphylm

The FDA will review the new application for the sublingual allergy film with a goal decision date in March 2027.

Updated on Oct. 15, 2026 in Allergies

FDA Accepts Aquestive Resubmission for Anaphylm

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The FDA has accepted the New Drug Application resubmission for Anaphylm, a sublingual film designed to treat Type I allergic reactions. The agency has set a PDUFA goal action date of March 16, 2027, for its final decision on the medication.

Why it matters

If approved, Anaphylm would become the first oral rescue medication available for individuals suffering from severe allergic reactions. This resubmission addresses specific concerns previously identified by the FDA in a January 2026 response letter.

The FDA has classified the filing as a Class 2 response following positive human factors and pharmacokinetic study results. Anaphylm utilizes a specialized polymer matrix-based epinephrine prodrug delivery technology.

The players

Aquestive Therapeutics

Aquestive Therapeutics is a pharmaceutical company based in New Jersey that develops advanced drug delivery platforms.

FDA

The FDA is the federal agency responsible for protecting public health by regulating the safety and efficacy of medical products in the United States.

The details

Aquestive Therapeutics submitted the new data on September 16, 2026, to resolve items raised during the initial January 2026 review. The company is simultaneously preparing for a potential product launch and a separate regulatory filing in Canada.

January 30, 2026: FDA issued a Complete Response Letter.
August 2026: Company announced positive study results.
September 16, 2026: Aquestive Therapeutics submitted the NDA resubmission.
October 15, 2026: FDA announced acceptance of the resubmission.
March 16, 2027: PDUFA goal action date.

The Big Picture

The FDA is following the standards established by the Prescription Drug User Fee Act to manage this regulatory review. This framework ensures a predictable timeline for evaluating new pharmaceutical applications against current safety requirements.

This development suggests a potential future option for severe allergy patients who may prefer an oral delivery method over traditional injectors. Final availability for patients depends on the upcoming regulatory decision and subsequent commercial rollout.

The takeaway

Patients currently relying on traditional emergency allergy treatments should continue following their existing medical protocols. The potential introduction of oral rescue medication remains subject to the ongoing federal review process.