Achieve Life Sciences announces FDA acceptance of cytisinicline new drug application for treatment of nicotine dependence for smoking cessation

Achieve Life Sciences

3 September 2025 - Achieve Life Sciences today announced that the US FDA has accepted the cytisinicline new drug application for a new treatment for smoking cessation in adults. 

The FDA has assigned a PDUFA targeted action date of 20 June 2026.

Read Achieve Life Sciences press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier , Registration