FDA Mistakenly Widened Approved Indication Of Vanda’s Hetlioz, Public Citizen Tells Agency

The FDA mistakenly expanded the use of Vanda Pharmaceuticals Inc.'s sleep disorder medication Hetlioz (tasimelteon) beyond the narrow patient group for which it originally was approved, the consumer group Public Citizen said in a June 11 petition to the agency.

The Food and Drug Administration approved Hetlioz in 2014 12 PLIR 178, 2/7/14. According to the original approval letter issued on Jan. 31, 2014, the FDA approved Hetlioz for the treatment of “non-24-hour sleep-wake disorder in blind patients without light perception,” Public Citizen said. Non-24 hour sleep-wake disorder is a chronic sleep disorder that occurs when individuals are unable ...