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# FDA Denys Hearing on Vanda Hetlioz Rejection
- URL: https://www.fdaweb.com/fda-denys-hearing-on-vanda-hetlioz-rejection/
- Published: 2025-03-07T12:00:00.000Z
- Updated: 2026-09-14T14:54:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158783

*Federal Register* notice: FDA is making available its decision to deny a request for a hearing on a recent CDER refusal to approve a Vanda supplemental NDA for Hetlioz (tasimelteon) capsules for treating insomnia characterized by difficulties with sleep initiation. The refusal was outlined in a 3/2024 complete response letter to Vanda stating that it could not be approved in its present form because the application did not provide substantial evidence of effectiveness and that the drug is safe for the proposed use. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2025-03-07/pdf/2025-03697.pdf?ref=fdaweb.com).