Achieve Life Sciences has received a Complete Response Letter from the FDA for its cytisinicline New Drug Application, citing deficiencies at a prior third-party manufacturing facility and incomplete product labeling. The FDA identified no issues with the drug's clinical efficacy or safety. The manufacturing facility had received an Official Action Indicated classification for general cGMP matters not specific to cytisinicline. Achieve has already partnered with Adare Pharma Solutions as its new primary commercial manufacturer and plans to resubmit the NDA in the fourth quarter of 2026, with potential approval in the first half of 2027.
Achieve Life Sciences IncFDA Complete Response Letter due to third-party manufacturing deficiencies delays approval.
Adare Pharma Solutions selected as new primary commercial manufacturer for cytisinicline.