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# Vanda Sues FDA to Allow Off-Label Promotion
- URL: https://www.fdaweb.com/vanda-sues-fda-to-allow-off-label-promotion/
- Published: 2025-04-14T12:00:00.000Z
- Updated: 2026-09-14T14:57:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159002

Vanda Pharmaceuticals has filed a lawsuit against FDA that seeks a declaratory judgment giving the company protection under the First Amendment to promote Hetlioz (tasimelteon) for the off-label use of treating jet lag. The drug is currently approved for treating non-24-hour sleep-wake disorder, and Vanda had sought a new indication for treating jet lag disorder in 2019, but the agency declined approval and recommended it conduct at least one additional adequate and well-controlled study. The company subsequently submitted two formal dispute resolution requests that were denied by FDA.

Vanda’s [complaint](http://www.fdaweb.com/download.php?file=vanda%5F2025%5Fco.pl%5Faint.pdf) includes proposed promotional materials and reprints of three peer-reviewed studies that have evaluated Hetlioz as a treatment for jet lag. The company asks the court to declare that these communications are truthful and non-misleading. Additionally, it seeks a court action to permanently enjoin FDA from taking any adverse action against Vanda or its employees or directors related to these communications.