Vanda Pharmaceuticals Drugs to Get More FDA Reviews to Resolve Legal Disputes
By Katherine Hamilton
Vanda Pharmaceuticals has agreed to a plan in which the Food and Drug Administration will conduct more reviews of two of its drugs to resolve disputes between the company and the agency.
Under the agreement, the FDA will conduct an expedited re-review of the partial clinical hold preventing long-term clinical studies of tradipitant, a drug developed but not approved to treat motion sickness. The review will be conducted by Nov. 26, Vanda said Wednesday.
The FDA will also continue its review of Vanda's new drug application for tradipitant, with the existing target action date of Dec. 30.
The FDA will also conduct an expedited re-review of Vanda's new drug application for Hetlioz, which is designed to treat jet lag, by Jan. 7, 2026. It will also consider alternative or narrowed indications for sleep-related issues.
Vanda and the FDA will seek a temporary pause on the ongoing proceedings for the company's drug application for tradipitant for the treatment of gastroparesis. They will also seek to pause Vanda's lawsuit challenging the FDA's practice of taking up to 12 months to decide new drug applications.
Vanda will also dismiss its lawsuits challenging the FDA's hold preventing studies of tradipitant for motion sickness, and regarding the company's request to provide information to prescribers and patients regarding Hetlioz's efficacy to treat jet lag.
Write to Katherine Hamilton at katherine.hamilton@wsj.com
(END) Dow Jones Newswires
October 01, 2025 17:59 ET (21:59 GMT)
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