Aquestive Therapeutics announced the FDA accepted its resubmission for Anaphylm and set a PDUFA goal date of March 16, 2027, following a previous Complete Response Letter.
SEC EDGAR, 2026-10-15: 8-K (Item 7.01, 9.01) — "complete response letter"
Aquestive Therapeutics announced the FDA accepted its resubmission for Anaphylm and set a PDUFA goal date of March 16, 2027, following a previous Complete Response Letter.
Company: Aquestive Therapeutics, Inc. (AQST) Filed: October 15, 2026, 8-K (Item 7.01, 9.01) Phrase: "Complete Response Letter" — "Aquestive submitted the resubmission to the Anaphylm NDA on September 16, 2026, following the August 2026 announcement of positive topline results from human factors and pharmacokinetic (PK) studies conducted to address the items raised in the FDA’s January 30, 2026, Complete Response Letter." What the filing says: The company announced that the FDA accepted its resubmission of the New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film, classifying it as a Class 2 response. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2027, for a decision. This resubmission, made on September 16, 2026, was in response to the FDA’s January 30, 2026, Complete Response Letter, and followed positive topline results from human factors and pharmacokinetic studies announced in August 2026. Two ways it goes: A. The FDA approves Anaphylm by the PDUFA goal date. B. The FDA issues another Complete Response Letter or requests additional information. Next date: March 16, 2027 (PDUFA goal date) Watch: FDA decision on Anaphylm NDA