---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-221784"
form_type: "8-K"
ticker: "VNDA"
cik: "0001347178"
company_name: "Vanda Pharmaceuticals Inc."
filed_at: "2024-09-19T23:59:59+00:00"
generated_at: "2026-05-31T03:32:30.890685+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-24-221784
- form_type: 8-K
- ticker: VNDA
- cik: 0001347178
- company_name: Vanda Pharmaceuticals Inc.
- filed_at: 2024-09-19T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1347178/000119312524221784/0001193125-24-221784-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1347178/000119312524221784/d809647d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-221784
- JSON: https://secwatch.observer/filing/0001193125-24-221784.json
- Plain text: https://secwatch.observer/filing/0001193125-24-221784.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.