---
schema_version: "secwatch.filing_event.v1"
accession: "0001356576-24-000018"
form_type: "8-K"
ticker: "SUPN"
cik: "0001356576"
company_name: "SUPERNUS PHARMACEUTICALS, INC."
filed_at: "2024-04-08T23:59:59+00:00"
generated_at: "2026-06-04T01:18:33.489327+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Supernus receives FDA Complete Response Letter for SPN-830 (apomorphine infusion device)

## Summary
- FDA issued CRL stating NDA for SPN-830 (apomorphine infusion) not ready for approval.
- Two areas: product quality (additional data submitted but not reviewed) and device master file from manufacturer.
- No clinical safety or efficacy issues identified as barriers to approval.
- FDA completed successful preapproval inspection of device manufacturer's facility in Feb 2024.
- Supernus plans to work with device manufacturer and FDA to resubmit NDA.

## SEC filing metadata
- accession: 0001356576-24-000018
- form_type: 8-K
- ticker: SUPN
- cik: 0001356576
- company_name: SUPERNUS PHARMACEUTICALS, INC.
- filed_at: 2024-04-08T23:59:59+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/1356576/000135657624000018/0001356576-24-000018-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1356576/000135657624000018/supn-20240408.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001356576-24-000018
- JSON: https://secwatch.observer/filing/0001356576-24-000018.json
- Plain text: https://secwatch.observer/filing/0001356576-24-000018.txt

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