FDA rejects dasotraline NDA for ADHD, calling for more data
The US Food and Drug Administration has issued a Complete Response Letter for the New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatment of attention-deficit hyperactivity disorder (ADHD), under development at Sunovion Pharmaceuticals, a US subsidiary of Japanese pharma company Sumitomo Dainippon Pharma (TYO: 4506).
Announced on Friday after Japanese stock exchanges had closed, the news sent Sumitomo Dainippon’s shares tumbling 9.39% to 2,143 yen in Monday (September 3) trading.
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