Vanda Pharmaceuticals’s new drug application (NDA) for tradipitant for the treatment of symptoms in gastroparesis was rejected by the US Food and Drug Administration, but the company still intends to file tradipitant in a different indication – motion sickness – by the end of the year.
Key Takeaways
- The FDA rejected Vanda’s NDA for tradipitant for the treatment of symptoms in gastroparesis due to concerns about safety and efficacy.
- Vanda has already sued the FDA over its request for a longer non-rodent toxicology study, and the CRL calls for additional clinical trials in gastroparesis
The company announced receipt of a complete response letter (CRL) for tradipitant in gastroparesis on 19 September
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