A court victory forces the Food and Drug Administration to re-examine rejected application for expanded indication. Years of Regulatory DisputesThe controversy began in 2018 when Vanda submitted a supplemental New Drug Application (sNDA) seeking to expand HETLIOZ’s approved uses beyond rare sleep disorders to include jet lag treatment. The court’s ruling was unambiguous: the FDA had violate” requirements under the Food, Drug, and Cosmetic Act by failing to properly process Vanda’s application. Appeals Court Delivers RebukeIn setting aside the agency’s action, the three-judge appellate panel delivered pointed criticism of how the FDA handled Vanda’s evidence. According to Vanda, HETLIOZ has the potential to fundamentally change the landscape of circadian resetting during transmeridian global travel.