# VNDA PDUFA Calendar: FDA Decision Dates & Catalyst Timeline

Canonical URL: https://biopharmsignal.com/pdufa-calendar/VNDA
Company: Vanda Pharmaceuticals

BioPharmSignal tracks active PDUFA and FDA decision milestones associated with VNDA.

## VNDA PDUFA Milestones

- 2024-04-02 — FDA Approval — FDA approved application. FDA recorded approval of FANAPT on April 2, 2024. This list-only historical record is sourced from the official FDA application dat...
  Company: Vanda Pharmaceuticals
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=22192
  Event detail: https://biopharmsignal.com/pdufa-calendar/VNDA/fanapt-nda-022192-suppl-23.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2024/april (April 2024)
- 2024-09-18 — CRL — FDA issued Complete Response Letter. The sponsor reported that FDA issued a Complete Response Letter for Tradipitant on September 18, 2024. This list-only hi...
  Company: Vanda Pharmaceuticals
  Source: https://www.sec.gov/Archives/edgar/data/1347178/000119312524221784/d809647dex991.htm
  Event detail: https://biopharmsignal.com/pdufa-calendar/VNDA/tradipitant-tradipitant-gastroparesis-nda.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2024/september (September 2024)
- 2025-12-30 — FDA Approval — FDA approved application. FDA recorded approval of NEREUS on December 30, 2025. This list-only historical record is sourced from the official FDA application...
  Company: Vanda Pharmaceuticals
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220152
  Event detail: https://biopharmsignal.com/pdufa-calendar/VNDA/nereus-nda-220152-orig-1.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/december (December 2025)
- 2026-02-20 — FDA Approval — FDA approved application. FDA recorded approval of BYSANTI on February 20, 2026. This list-only historical record is sourced from the official FDA applicatio...
  Company: Vanda Pharmaceuticals
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220358
  Event detail: https://biopharmsignal.com/pdufa-calendar/VNDA/bysanti-nda-220358-orig-1.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/february (February 2026)

## Related Pages

- Company page: https://biopharmsignal.com/company/VNDA
- Interactive PDUFA Calendar: https://biopharmsignal.com/pdufa-calendar

## FAQ

### What does the VNDA PDUFA calendar show?

It shows active PDUFA and FDA decision milestones associated with VNDA, including decision dates, application stage, and summary details when available.
### Where can I find more context for VNDA?

Use the BioPharmSignal company page for VNDA to read related news, stock data, sector context, and company-specific updates.
### Are these dates investment advice?

No. PDUFA dates are research inputs, not investment recommendations. Always review primary sources and understand the clinical and regulatory context.