FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Sunovion Draws Complete Response Letter for ADHD Drug

Sept. 13, 2018

The FDA issued a complete response letter in response to Sunovion’s NDA for dasotraline for the treatment of ADHD.

The application included data from 2,500 children and adults in multiple safety and efficacy studies, along with two long-term safety studies. The agency called for more clinical data on the drug’s tolerability and efficacy.

The company plans to meet with the agency to discuss next steps and is confident about the drug’s prospects, according to Antony Loebel, Sunivion’s executive vice president and chief medical officer.

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