FDA identifies deficiencies in Vanda's sNDA for HETLIOZ insomnia; Vanda alleges FDCA violation

Vanda Pharmaceuticals Inc.

FDA notified Vanda on Feb 4, 2024 of deficiencies in sNDA for HETLIOZ (tasimelteon) for insomnia; no details disclosed.
Vanda claims FDA violated FDCA by missing statutory deadline of Oct 31, 2023, to approve or provide a hearing.
sNDA submitted May 4, 2023; PDUFA target date was March 4, 2024; deficiencies preclude labeling discussions.
Vanda is also challenging FDA approvals of generic HETLIOZ, which have been marketed since 2023.

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