India, June 22 -- Achieve Life Sciences, Inc. (ACHV), a late-stage pharmaceutical company, announced that the U.S. Food and Drug Administration has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of Cytisinicline as a treatment for nicotine dependence.
The CRL cited deficiencies related to current Good Manufacturing Practice (cGMP) observations at a third-party manufacturing facility and final product labeling that was not completed by the FDA's action date. There were no discrepancies regarding the clinical efficacy or safety of cytisinicline.
Cytisinicline is a plant-derived alkaloid that exhibits a strong binding affinity for nicotine acetylcholine receptors in the brain. It is designed to mitigate the intens...