FDA issues Complete Response Letter for Vanda's HETLIOZ insomnia sNDA

Vanda Pharmaceuticals Inc.

Received CRL on March 4, 2024 for HETLIOZ (tasimelteon) to treat insomnia with sleep initiation difficulties.
FDA stated deficiencies precluding approval; sNDA cannot be approved in present form.
Vanda reviewing CRL and evaluating next steps; no specific financial impact disclosed.
PDUFA date was March 4, 2024; FDA had flagged deficiencies on February 4, 2024.

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