Achieve Life Sciences Receives Complete Response Letter from FDA
Achieve Life Sciences announced that it has received a complete response letter, or CRL, from the FDA regarding the new drug application, or NDA, for cytisinicline. The CRL 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. The deficiencies cited in the CRL concern Achieve's prior third-party manufacturing facility, which received an Official Action Indicated classification from the FDA for general cGMP matters at the facility that are not specific to cytisinicline. As the Company disclosed on April 15, 2026, it expected to receive this CRL on or before its June 20 PDUFA date and had previously partnered with U.S.-based Adare Pharma Solutions as its new primary commercial manufacturing partner. Achieve has completed the analytical method technology transfer to Adare's facility, successfully manufactured its first cytisinicline engineering batch, and fully qualified all testing procedures at the site. Achieve intends to resubmit its NDA in the fourth quarter of 2026, naming Adare as its primary manufacturing partner, with potential FDA approval in the first half of 2027, followed by U.S. commercial launch.
