Achieve Life Sciences receives FDA Complete Response Letter for cytisinicline NDA over third-party manufacturing deficiencies
- FDA cited deficiencies at the third-party manufacturing partner, with no clinical efficacy or safety issues identified.
- Achieve plans to resubmit the cytisinicline NDA in Q4 2026 using a new manufacturing partner.
- The company is targeting potential FDA approval for cytisinicline in the first half of 2027.
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