FDA Issues CRL to Achieve Life Sciences (ACHV) for Cytisinicline NDA Over Manufacturing Concerns

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Achieve Life Sciences (ACHV) on June 21, 2026, for its New Drug Application (NDA) for Cytisinicline. The CRL cited deficiencies related to Current Good Manufacturing Practice (CGMP) at a third-party contract manufacturing organization, preventing immediate approval of the smoking cessation treatment. Achieve Life Sciences confirmed the CRL did not identify any issues with Cytisinicline's clinical efficacy or safety data. The company plans to work with the contract manufacturer to address the identified manufacturing deficiencies and intends to resubmit the NDA promptly. Cytisinicline is an investigational drug designed for smoking cessation and nicotine dependence.