Note: APPROVED ON the PDUFA date, 2026-04-30. Brand name: AUVELITY (dextromethorphan HBr and bupropion HCl). New indication: agitation associated with dementia due to Alzheimer's disease — this was an sNDA adding a second indication to a brand first approved in Aug 2022 for major depressive disorder, which is exactly why the auto-matcher found "no FDA approval found in window": Drugs@FDA logs this as a supplement to the existing NDA, not a new drug approval, so any scan of new-approval records will keep missing it. Recommend matching sNDA outcomes on application-supplement records or manual PDUFA outcome entry rather than the new-approval feed. Source: https://www.sec.gov/Archives/edgar/data/1579428/000119312526197857/axsm-20260430.htm
Drug Information
- Application Type
- sNDA
- FDA Designations
- BreakthroughPriority Review
- Indication
- Agitation associated with Alzheimer's disease
- Approved As
- AXS-05 (dextromethorphan-bupropion)
Filing Details
- Company
- Axsome Therapeutics, Inc. →
- Stock Ticker
- AXSM
- SEC CIK
- 0001579428
- Source
- GlobeNewswire →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
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Data sourced from SEC EDGAR filings. Last updated: 2026-04-10. Report an issue