22 June 2026 - Achieve Life Sciences today announced that it has received a complete response letter from the US FDA regarding the new drug application for cytisinicline. 

The complete response letter relates to outstanding manufacturing-related observations from a current Good Manufacturing Practice inspection of a third-party manufacturing facility and to final product labeling that was not completed by the FDA’s action date. The FDA identified no deficiencies regarding the clinical efficacy or safety of cytisinicline.

Read Achieve Life Sciences press release