Vanda Pharmaceuticals Secures Victory Over FDA in Jet Lag Disorder Treatment Dispute
ByAinvest
Monday, Aug 18, 2025 8:53 am ET1min read
VNDA--
Vanda Pharmaceuticals has secured a victory over the FDA in its dispute regarding the approvability of Hetlioz (tasimelteon) to treat jet lag disorder. The appeals court has remanded the case back to the FDA, where Vanda anticipates approval of its supplemental New Drug Application or a hearing. The FDA initially rejected the application in 2018.
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