Achieve Life Sciences, Inc. · 完整回應函 (NDA 218995)

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ADMINISTRATION i Lk YN U.S. FOOD & DRUG NDA 218995 COMPLETE RESPONSE Achieve Life Sciences, Inc. 22722 29th Dr. SE, Suite 100 Bothell, WA 98021 Attention: | Sarah Telzrow Vice President, Regulatory Affairs Dear Sarah Telzrow: Please refer to your new drug application (NDA) dated and received June 20, 2025, and your amendments, submitted under for cytisinicline tablet, © . We have completed our review of this application, as amended, and have determined that we cannot approve this application in its present form. We have described our reasons for this action below and, where possible, our recommendations to address these issues. FACILITY INSPECTIONS (1) Following a CGMP inspection of Loey listed in this application, FDA conveyed deficiencies to the representative of the facilit

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