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FDA again rejects Vanda’s Hetlioz for jet lag after yearslong dispute and ‘long‑shot’ re‑review

2 weeks ago talkbio0Tagged Circadian Rhythms, Clinical Trial Design, collaborative framework agreement, decision letter, expansion, Hetlioz, jet lag disorder, Labels (device), NDA, phase advance protocol, Rejection, Sleep Disorders, Supplement, tasimelteon, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals; Hetlioz; tasimelteon; jet lag disorder; FDA rejection; supplemental NDA; decision letter; phase advance protocol; circadian rhythm; clinical trial design; collaborative framework agreement; D.C. Circuit ruling; label expansion; sleep disorder drug; regulatory dispute