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FDA对Vanda tradipitant部分临床搁置延长的重新审查
2025-11-29 00:25
- The US FDA is extending by a matter of days a re-review of a partial clinical hold on long-term studies of Vanda Pharmaceuticals' (VNDA) tradipitant for motion sickness.
- The agency was supposed to complete its review by Nov. 26, but due to personnel changes in the Center for Drug Evaluation and Research, that date has been extended to Dec. 5.
- The hold was placed due to safety concerns and a lack of chronic toxicity data.
- Separately, Vanda said that the FDA action date for its tradipitant NDA for prevention of vomiting caused by nausea is still scheduled for Dec. 30, adding that the agency has recently provided comments on proposed labeling, and labeling discussions are underway.
More on Vanda Pharmaceuticals
- Vanda Pharmaceuticals: Commercial Execution Meets Pipeline Optionality
- Vanda Pharmaceuticals Inc. (VNDA) Q3 2025 Earnings Call Transcript
- Vanda's tradipitant can significantly reduce nausea in those taking a GLP-1
- Vanda a new buy at B. Riley on 'historic discount'
- Seeking Alpha’s Quant Rating on Vanda Pharmaceuticals
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