Proposal to Refuse to Approve a New Drug Application for TRADIPITANT; Opportunity for a Hearing
Published Date: 1/16/2025
Notice
Summary
The FDA is thinking about saying no to Vanda Pharmaceuticals' new drug, TRADIPITANT, in its current form. Vanda can ask for a hearing to explain why the drug should be approved. If you want to speak up or support the hearing, you’ve got until mid-February and mid-March 2025 to send in your requests and info.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
FDA Identifies Major Data Gaps
FDA identified specific deficiencies in the submitted clinical and nonclinical data: Study 3301, Group 1 failed to show statistically significant efficacy versus placebo; Study 2301 had methodological shortcomings; post hoc analyses are insufficient; clinical safety data are limited to 12 weeks; and nonclinical studies did not adequately characterize long-term safety. FDA recommended Vanda conduct two new adequate and well-controlled trials in adults with idiopathic or diabetic gastroparesis and a chronic repeat-dose toxicity study in a nonrodent species to address these deficiencies.
FDA Proposes Refusal of TRADIPITANT
The FDA proposes to refuse approval of Vanda Pharmaceuticals' new drug application (NDA 218489) for TRADIPITANT capsules, 85 mg, in its present form because the agency found the application does not provide substantial evidence of effectiveness and does not demonstrate safety for the proposed use. If no timely hearing request is filed, FDA will issue a notice refusing to approve the application.
Hearing Opportunity and Deadlines
Vanda and other interested persons may request a hearing on FDA's proposal; hearing requests must be submitted by February 18, 2025, and supporting data, analyses, or other comments must be submitted by March 17, 2025. The notice warns that failure to request a hearing in the required manner and time will waive the opportunity and FDA will issue a refusal to approve the application.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Related Federal Register Documents
2026-17562, Arms Sales Notification
The DoD (referred to herein as "the Department," "Department of War" or "DoW") is publishing the unclassified text of an arms sales notification.
2026-17589, Leila Kump, M.D.; Decision and Order
2026-17633, Combined Notice of Filings
2026-17618, Oil Country Tubular Goods From Austria, Taiwan, and the United Arab Emirates: Postponement of Preliminary Determinations in the Less-Than-Fair-Value Investigations
2026-17634, Combined Notice of Filings #2
2026-17547, Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Delay the Implementation of SR-ISE-2026-18
Previous / Next Documents
Previous: 2025-01026, Proposed Flood Hazard Determinations
FEMA is updating flood risk maps for several communities, which could change flood zones and insurance rules. If you live in these areas, your flood insurance costs or building rules might change. You’ve got until April 16, 2025, to check the new maps and share your thoughts before the updates become official.
Next: 2025-01028, Recommendations To Reduce the Risk of Transfusion-Transmitted Malaria; Draft Guidance for Industry; Availability
The FDA is rolling out new draft rules to help blood banks better spot and stop malaria from sneaking into blood donations. Blood centers will start using special tests to check donors who might have malaria, making transfusions safer for everyone. If you’re involved in blood collection, get ready to share your thoughts by March 17, 2025, before these changes become official!