Vanda Ends Lawsuits Against FDA in Broad Settlement, Paving Way for Drug Review Progress
Vanda Pharmaceuticals has agreed to end its litigation against the U.S. Food and Drug Administration (FDA) as part of a new collaborative framework between the company and the agency aimed at resolving ongoing regulatory disputes1.
Key elements of the agreement include the dismissal of Vanda's lawsuits related to information provision for Hetlioz and an expedited FDA re-review of two distinct matters:
a partial clinical hold on tradipitant's long-term studies for motion sickness (due by November 26, 2025), and Vanda’s supplemental new drug application (sNDA) for Hetlioz in jet lag disorder (review by January 7, 2026)1.
This deal comes after a federal appeals court ruled in favor of Vanda, criticizing the FDA's prior refusal to approve Hetlioz for jet lag disorder and remanding the case for further agency action or a required hearing234.
The court decision marked a major shift in regulatory procedure, requiring the FDA to substantively consider evidence submitted by sponsors and curtailing the agency's ability to issue summary judgment denials when genuine scientific disputes exist34.
The agreement also temporarily pauses related legal proceedings (including under Part 12, stemming from a recent D.C. Circuit decision in Vanda Pharmaceuticals v. FDA, No. 24-1049), fostering a more collaborative approach to the review and potential approval of Vanda’s drugs1.
The FDA’s PDUFA action date for the motion sickness indication of tradipitant remains set for December 30, 20251.
Sources:
1. https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-collaborative-framework-for-resolution-of-disputes-with-the-us-food-and-drug-administration-302573077.html
2. https://www.prnewswire.com/news-releases/in-a-major-win-for-vanda-a-federal-appeals-court-overturns-fdas-order-denying-approval-of-hetlioz-for-the-treatment-of-jet-lag-disorder-302531842.html
3. https://www.arnoldporter.com/en/perspectives/advisories/2025/08/lessons-from-vanda-v-fda
4. https://www.thepharmaletter.com/pharmaceutical/vanda-wins-appeals-court-fight-over-fda-jet-lag-ruling