Cytisinicline
FDA PDUFA Target Action Date · Achieve Life Sciences, Inc.
Note: CRL confirmed by explicit company statement. Press release "Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDA", dateline "SEATTLE and VANCOUVER, British Columbia, June 22, 2026 (GLOBE NEWSWIRE)". Indication: nicotine dependence / smoking cessation in adults (NDA submitted June 2025, accepted Sept 2025, PDUFA 2026-06-20). Subheads: "CRL Cites Deficiencies at Third-Party Manufacturing Facility" and "No Efficacy or Clinical Safety Deficiencies Identified". FDA acted 2026-06-22 (target was 2026-06-20). Source: https://ir.achievelifesciences.com/news-events/press-releases/detail/264/achieve-life-sciences-receives-complete-response-letter-from-fda-for-cytisinicline-nda
Drug Information
- Drug Name
- Cytisinicline (CT.gov)
- Application Type
- NDA
- FDA Designations
- Breakthrough
- Indication
- Nicotine dependence / smoking cessation
- Approved As
- Cytisinicline
Filing Details
- Company
- Achieve Life Sciences, Inc.
- Stock Ticker
- ACHV
- SEC CIK
- 0000949858
- Source
- Company IR →
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
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-04-10. Report an issue