FDA Cites Manufacturing Issues for Cytisinicline

Application supported by Phase 3 smoking-cessation data and long-term safety findings.

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The FDA issued a Complete Response Letter for cytisinicline, citing manufacturing issues at a third-party facility and incomplete product labeling.
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No deficiencies related to the clinical efficacy or safety of cytisinicline were identified by the FDA.
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Achieve Life Sciences plans to resubmit the New Drug Application in the fourth quarter of 2026, reflecting a new manufacturing partnership.
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Cytisinicline has shown greater smoking abstinence rates in Phase 3 trials compared to placebo, with significant safety data from over 400 participants.
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Achieve Life Sciences is developing cytisinicline for smoking cessation and has received FDA Breakthrough Therapy designation for e-cigarette cessation.

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