Vanda Pharmaceuticals and FDA Agree on Collaborative Framework for Resolution of Disputes over Hetlioz and Tradipitant
Key Takeaways
- Vanda and FDA's agreement includes expedited re-reviews of Tradipitant and Hetlioz applications, with target action dates in late 2025 and early 2026.
- The collaborative framework involves pausing ongoing legal proceedings and dismissing lawsuits to streamline the drug approval process.
Vanda Pharmaceuticals collaborates with the FDA to expedite reviews for Hetlioz and Tradipitant, aiming to resolve ongoing disputes and approvals.
Vanda Pharmaceuticals announced it has agreed on a collaborative framework with FDA, aiming to resolve certain disputes regarding Hetlioz. The collaborative agreement follows a federal court’s decision to overturn FDA’s order denying Hetlioz’s approval as a treatment for jet lag disorder.2
What does the collaborative agreement entail?
Per the terms of collaborative framework agreement, FDA will conduct an expedited re-review on the partial clinical hold that’s preventing long-term clinical studies of Tradipitantas a treatment for motion sickness by late November of this year.1 FDA is expected to continue its review of the New Drug Application (NDA) from Vanda for this specific indication, and have set the Prescription Drug User Fee Act (PDUFA) target action date for December 30, 2025.1
Additionally, FDA will conduct an expedited re-review of Vanda's supplemental New Drug Application (sNDA) for Hetlioz for the treatment of jet lag disorder by the target action date of January 7, 2026, while also including consideration for alternative or niche indications focusing on the sleep-related aspects of jet lag disorder.1 Vanda and FDA are expected to temporarily pause the Part 12 proceedings from D.C. Circuit's recent decision in Vanda Pharmaceuticals v. FDA, No. 24-1049.1 Along with pausing Part 12 proceedings, FDA and Vanda both aim to reach a temporary pause in ongoing administrative proceedings before FDA Commissioner Marty Makary, for Vanda's NDA for Tradipitant for indication in gastroparesis, with a target date of January 7, 2026.The last pause mentioned in the agreement, aims to halt Vanda's lawsuit challenging FDA's practice in deciding new drug applications taking up to 12 months, rather than the statutory 180 days.1
Along with the pauses in multiple Vanda v. FDA court cases, Vanda announced it is dismissing its lawsuit against FDA's partial clinical hold preventing long term studies of Tradipitant for the treatment of motion sickness. Vanda is also expected to dismiss its lawsuit regarding Vanda's request to provide information to prescribers and patients regarding the efficacy of Hetlioz in Jet Lag Disorder.1
Vanda and FDA’s most recent legal dispute
The most recent dispute between Vanda and FDA came back in August of this year, which resulted in a
Sources
- Vanda Pharmaceuticals Announces Collaborative Framework for Resolution of Disputes with the U.S. Food and Drug Administration Vanda Pharmaceuticals October 1, 2025
https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-collaborative-framework-for-resolution-of-disputes-with-the-us-food-and-drug-administration-302573077.html - In a Major Win for Vanda, a Federal Appeals Court Overturns FDA's Order Denying Approval of Hetlioz for the Treatment of Jet Lag Disorder Vanda Pharmaceuticals August 18, 2025
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
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