Vanda Pharmaceuticals Inc. (VNDA) has sought FDA approval for a new formulation of its marketed drug Hetlioz and a new indication for that med. Hetlioz in capsule formulation is already approved to treat totally blind adults with non-24-hour sleep-wake disorder. The drug was launched in the U.S. in 2014 and in the EU in 2016.Non-24-hour sleep-wake disorder is a condition that occurs almost exclusively in people who are completely blind, where patients are unable to synchronize their internal body clock to the standard 24-hour light-dark cycle, and therefore they do not necessarily associate night with sleep, and day with being awake.The new approvals that are being sought for are for a liquid formulation of Hetlioz and for the expanded indication in the treatment of adults and children with Smith-Magenis Syndrome. The FDA decision is expected on December 1, 2020.Last August, the regulatory agency had turned down the company’s request to approve Hetlioz in treating jet lag disorder.The drug generated net product sales of $116.5 million in the first nine months of 2020, compared to $104.4 million in the same period in 2019.VNDA closed Friday’s (Nov.27, 2020) trading at $12.41, up 2.48%.