Aquestive Therapeutics, Inc.
0 products tracked · names used in filings: Aquestive Therapeutics, Inc.
Upcoming milestones
Libervant: PDUFA target action date (acute treatment of seizure clusters/acute repetitive seizures in patients twelve years of age and older)
Aquestive Therapeutics, Inc. (AQST); diazepam; NDA; status: set; "Final FDA approval for patients twelve years of age and older is subject to expiration of the orphan drug exclusivity for Valtoco® on January 10, 2027, and final FDA action, with a PDUFA goal date of March 23, 2027."; filed 2026-11-03 · source
Anaphylm: PDUFA target action date
Aquestive Therapeutics, Inc. (AQST); dibutepinephrine; NDA; status: set; "Food and Drug Administration (“FDA”); our belief that the New Drug Application (“NDA”) resubmission addresses the matters identified by the FDA in the Complete Response Letter (“CRL”) dated January 30, 2026; the FDA’s review of the accepted Class 2 resubmission of the NDA and the Prescription Drug User Fee Act…"; filed 2026-11-05 · source
Recent milestones
No recent milestones.
Products
No products recorded.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.