Achieve Life Sciences Receives FDA Complete Response Letter for Cytisinicline
Achieve Life Sciences (ACHV) received a complete response letter from the US Food and Drug Administration for its new drug application for cytisinicline related to manufacturing observations at a third-party facility, the company said Monday.The FDA identified no deficiencies related to the efficacy or safety of cytisinicline, according to a statement.The manufacturing observations involve a former third-party facility that received an Official Action Indicated classification for current good manufacturing practice matters that are not specific to cytisinicline, according to the company.Achieve Life Sciences said it expects to resubmit its new drug application in Q4 after transitioning commercial manufacturing to US-based Adare Pharma Solutions.Shares of the company were up over 8% in Monday trading.Price: $5.26, Change: $+0.41, Percent Change: +8.46%
