Aquestive announces FDA identified deficiencies in NDA for Anaphylm

Aquestive Therapeutics (AQST) provided an update on the regulatory approval of Anaphylm and its business. “As part of its ongoing review of the Company’s NDA for Anaphylm, the FDA notified us that it had identified deficiencies in the NDA that preclude discussion of labeling and post-marketing commitments at this time,” said Dan Barber, President and Chief Executive Officer of Aquestive. “Although the notification did not specify the deficiencies, Aquestive is working to understand and resolve the concerns. The FDA stated that the notification does not reflect a final decision on the pending application and the FDA’s review remains ongoing.”