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# FDA Flags Deficiencies in Aquestive’s Anaphylm NDA
- URL: https://www.fdaweb.com/fda-flags-deficiencies-in-aquestives-anaphylm-nda/
- Published: 2026-01-09T12:00:00.000Z
- Updated: 2026-09-14T15:30:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160464

FDA has told Aquestive Therapeutics that deficiencies have been identified in the company’s NDA for Anaphylm that currently preclude labeling and post-marketing commitments discussions, though the agency emphasized that its review remains ongoing and no final decision has been made.

In a regulatory update, the company said FDA did not specify the deficiencies in its notification. Chief executive **Dan Barber** said the company is working to understand and address the issues and underscored that the letter does not represent an approval decision. Anaphylm’s user fee review action target date is 1/31.

According to the company, FDA indicated it does not plan to issue a Discipline Review Letter but may request additional information during the remainder of the review. Aquestive warned that delays in receiving details on the deficiencies could push back a potential approval.

Anaphylm is a sublingual film formulation of an epinephrine prodrug intended for the treatment of severe allergic reactions, including anaphylaxis. The company said the development program demonstrated a pharmacokinetic profile comparable to leading epinephrine auto-injectors and a safety profile consistent with epinephrine.