Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDA
Achieve received a Complete Response Letter from the FDA regarding its cytisinicline NDA, citing manufacturing facility deficiencies and labeling issues but explicitly identifying no clinical efficacy or safety deficiencies. The company, which had previously signaled the likelihood of this action, has partnered with Adare Pharma Solutions to resolve the third-party facility concerns and plans to resubmit the NDA in Q4 2026.
Key figures
- Drug Name
- cytisinicline
- Guidance
- resubmit NDA in Q4 2026; potential FDA approval in H1 2027
- Phase Of Trial
- Phase 3
- Participants
- >1500
- Pivotal trials
- ORCA-2, ORCA-3
AI analysis
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