FDA Denies Public Citizen Petition on Labeling for Hetlioz Capsules

The FDA turned down Public Citizen’s request to limit the indication for Vanda Pharmaceuticals’ non-24-hour sleep-wake disorder drug Hetlioz (tasmelteon).

The advocacy group petitioned the agency in 2015 limit the indication to “blind patients without light perception” who had non-24 sleep-wake disorder. Vanda was approved in 2014 for “totally blind individuals,” effectively expanding the approval to anyone diagnosed with the disorder.

In response to the petition, CDER Director Janet Woodcock told Public Citizen that the agency continues to believe that the benefits of Hetlioz outweigh the risks and that the risks are adequately addressed in the current labeling.