FDA rejects Achieve Life Sciences drug application over manufacturing issues
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Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDA
June 22, 2026 8:30 AM EDTCRL Cites Deficiencies at Third-Party Manufacturing Facility
No Efficacy or Clinical Safety Deficiencies Identified
SEATTLE and VANCOUVER, British Columbia, June 22, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Achieve or the Company) (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for cytisinicline. The CRL relates to outstanding... More
