FDA rejects Sunovion’s ADHD drug dasotraline

pharmafile | September 3, 2018 | News story | Sales and Marketing ADHD, FDA, dasotraline, drug, sunovion 

The US Food and Drug Administration (FDA) have rejected American pharma firm Sunovion’s application to market dasotraline for the treatment of Attention Deficit Hyperactive Disorder (ADHD).

The FDA said that the dual acting dopamine and norepinephrine reuptake inhibitor (DNHI) could not be approved in its current form. The US agency indicated that additional clinical data regarding the tolerability and efficacy of the ADHD drug were needed.

Sunovion however still intend to gain approval for the ADHD medication. The privately owned company intend to meet with the agency in preparation for a resubmission.

“While we are disappointed with the FDA’s decision, we remain confident in the future of dasotraline,” said Antony Loebel, the firm’s chief medical officer and head of Global Clinical Development for Sumitomo Dainippon Pharma Group.

The company is also in the process of developing dasotraline for the treatment of moderate to severe binge eating disorders in adults. A US marketing application is set to be filed at the beginning of 2019.

Louis Goss

Related Content

FDA approves ANDA of 20mg generic Nitisinone capsules

Analog Pharma and Dipharma have announced that the US Food and Drug Administration (FDA) has …

FDA approves Pfizer’s RSV vaccine for older adults

Global pharmaceutical company Pfizer has announced that the US Food and Drug Administration (FDA) has …

Bristol Myers Squibb’s NDA accepted by FDA

Global pharmaceutical company Bristol Myers Squibb (BMS) has announced that its New Drug Application (NDA) …

Latest content