Cytisinicline NDA Delayed: Achieve Targets Resubmission and 2027 Approval Timeline
Tuesday, June 23, 2026
Posted by: Natalia Gromov
Achieve Life Sciences announced it received a Complete Response Letter (CRL) from the FDA for its cytisinicline NDA, citing issues related to a third‑party manufacturer’s facility and product labeling rather than clinical effectiveness. The company plans to address these manufacturing and labeling concerns then to resubmit the application later this year, which would shift any potential FDA approval into early 2027.
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