US FDA declines to approve Achieve Life Sciences' smoking-cessation drug

The U.S. Food and Drug Administration has declined to approve Achieve Life Sciences' drug to treat nicotine dependence in adults, the company said on Monday.

The company said the FDA issued a complete response letter citing outstanding manufacturing-related observations at a third-party manufacturing facility and final product labeling that was not completed by the agency's action date.

The FDA did not identify any deficiencies related to the clinical efficacy or safety of the drug, Achieve said.

The experimental drug, called cytisinicline, is a plant-derived compound aimed at helping adults quit smoking by reducing nicotine cravings and withdrawal symptoms, including irritability, anxiety and sleep problems.

Achieve said it plans to resubmit the application in the fourth quarter of 2026, with potential FDA approval in the first half of 2027 and a U.S. commercial launch to follow if approved.

(Reporting by Kunal Das and Kamal Choudhury in Bengaluru; Editing by Diti Pujara and Jonathan Ananda)

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This story was originally published June 22, 2026 at 8:04 AM.