Achieve Life Sciences Shifts Cytisinicline Production to Ohio Amid FDA Refiling Plans

Key Facts

1Achieve Life Sciences completed the transfer of cytisinicline manufacturing to Adare Pharma Solutions in Ohio.

2The company expects to resubmit its New Drug Application (NDA) in Q4 2026.

3The move follows an Official Action Indicated (OAI) classification from the FDA for a previous third-party manufacturing facility.

Achieve Life Sciences has successfully completed the manufacturing transfer of its nicotine-dependence drug, cytisinicline, to Adare Pharma Solutions in Ohio. This strategic relocation follows an Official Action Indicated (OAI) classification from the FDA regarding a previous third-party manufacturing site. By shifting production to a U.S.-based facility, the company aims to mitigate regulatory risks and ensure supply chain redundancy ahead of its commercial goals. Achieve Life Sciences now expects to resubmit its New Drug Application (NDA) in the fourth quarter of 2026. This move is viewed as a critical step in resolving previous compliance bottlenecks that had clouded the drug's path to market. The company remains focused on a planned commercial launch in 2027, contingent upon regulatory approval.