---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-024112"
form_type: "8-K"
ticker: "VNDA"
cik: "0001347178"
company_name: "Vanda Pharmaceuticals Inc."
filed_at: "2024-02-05T23:59:59+00:00"
generated_at: "2026-06-06T09:00:39.701694+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA identifies deficiencies in Vanda's sNDA for HETLIOZ insomnia; Vanda alleges FDCA violation

## Summary
- FDA notified Vanda on Feb 4, 2024 of deficiencies in sNDA for HETLIOZ (tasimelteon) for insomnia; no details disclosed.
- Vanda claims FDA violated FDCA by missing statutory deadline of Oct 31, 2023, to approve or provide a hearing.
- sNDA submitted May 4, 2023; PDUFA target date was March 4, 2024; deficiencies preclude labeling discussions.
- Vanda is also challenging FDA approvals of generic HETLIOZ, which have been marketed since 2023.

## SEC filing metadata
- accession: 0001193125-24-024112
- form_type: 8-K
- ticker: VNDA
- cik: 0001347178
- company_name: Vanda Pharmaceuticals Inc.
- filed_at: 2024-02-05T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1347178/000119312524024112/0001193125-24-024112-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1347178/000119312524024112/d772316d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-024112
- JSON: https://secwatch.observer/filing/0001193125-24-024112.json
- Plain text: https://secwatch.observer/filing/0001193125-24-024112.txt

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