The FDA Declined To Approve Vanda's New Drug Application Of Tradipitant For The Treatment Of Symptoms In Gastroparesis, Providing Vanda With A Complete Response Letter
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The FDA has declined to approve Vanda Pharmaceuticals' new drug application for Tradipitant, intended for treating gastroparesis symptoms. Vanda received a complete response letter from the FDA.
September 19, 2024 | 11:02 am
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Vanda Pharmaceuticals faced a setback as the FDA declined to approve its drug Tradipitant for gastroparesis, issuing a complete response letter.
The FDA's decision not to approve Tradipitant is a significant setback for Vanda Pharmaceuticals, likely leading to a negative short-term impact on its stock price. The complete response letter indicates that the FDA has concerns or requires additional information, which could delay the drug's market entry and affect investor sentiment.
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