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# FDA Decision Denying Vanda sNDA Hearing
- URL: https://www.fdaweb.com/fda-decision-denying-vanda-snda-hearing/
- Published: 2024-03-06T12:00:00.000Z
- Updated: 2026-09-14T14:24:39.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156499

*Federal Register* notice: FDA is announcing its decision to deny a request for a hearing on a CDER-proposed decision to not approve a Vanda Pharmaceuticals supplemental NDA for Hetlioz (tasimelteon) capsules, 20 milligrams (mg) for treating jet lag disorder. “Based on a review of the parties’ submissions, FDA finds that there is no genuine and substantial issue of fact justifying a hearing on CDER’s proposal to refuse to approve sNDA 205677-004,” a [just-posted order](https://downloads.regulations.gov/FDA-2022-N-2390-0033/attachment%5F1.pdf?ref=fdaweb.com) from the agency says. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-03-06/pdf/2024-04735.pdf?ref=fdaweb.com).