Vanda's HETLIOZ gets manufacturing supplement approval from FDA
FDA approved a CMC supplement for Vanda Pharmaceuticals' tasimelteon capsule HETLIOZ, with updated label and letter dated July 29, 2026.
This week's only item for Vanda Pharmaceuticals concerns a manufacturing update to its approved sleep drug HETLIOZ.
- HETLIOZ (tasimelteon), a 20MG oral capsule, received approval for Supplement 13, a Manufacturing (CMC) submission, with a submission status date of 2026-07-271. The associated label and approval letter documents are dated July 29, 2026.
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