Achieve Life Sciences Reaches Agreement with the FDA on Long-Term Cytisinicline Exposure Data Requirements for NDA Submission
ACHVAchieve Life Sciences(ACHV) Newsfilter·2024-02-29 21:01

SEATTLE and VANCOUVER, British Columbia, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the adequacy and timing of long- term cytisinicline exposure data requirements for a New Drug Application (NDA). During pre-NDA discussion ...