FDA Cites Manufacturing Issues for Cytisinicline - Takeaways - MDSpire

FDA Cites Manufacturing Issues for Cytisinicline

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

  • By

  • Kathryn Wighton

  • June 22, 2026

  • 3 min

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  • 1

    The FDA issued a Complete Response Letter for cytisinicline, citing manufacturing issues at a third-party facility and incomplete product labeling.

  • 2

    No deficiencies related to the clinical efficacy or safety of cytisinicline were identified by the FDA.

  • 3

    Achieve Life Sciences plans to resubmit the New Drug Application in the fourth quarter of 2026, reflecting a new manufacturing partnership.

  • 4

    Cytisinicline has shown greater smoking abstinence rates in Phase 3 trials compared to placebo, with significant safety data from over 400 participants.

  • 5

    Achieve Life Sciences is developing cytisinicline for smoking cessation and has received FDA Breakthrough Therapy designation for e-cigarette cessation.

Original Source(s)

FDA Cites Manufacturing Issues for Cytisinicline

  • by Kathryn Wighton

  • June 22, 2026

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