FDA issues Complete Response Letter declining Vanda's tradipitant NDA for gastroparesis

Vanda Pharmaceuticals Inc.

FDA declined to approve tradipitant for gastroparesis on Sept 18, 2024; issued CRL citing need for additional studies.
FDA action was delayed by over 185 days, Vanda says fails requirements of FDCA.
Vanda believes application met substantial evidence standard and plans to continue pursuing approval.
Separate NDA for tradipitant in prevention of vomiting from motion sickness planned later this year.
Expanded access program continues for several dozen gastroparesis patients.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.