---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-22-004549"
form_type: "8-K"
ticker: "UTHR"
cik: "0001082554"
company_name: "UNITED THERAPEUTICS Corp"
filed_at: "2022-01-18T23:59:59+00:00"
generated_at: "2026-06-27T17:25:38.249299+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA accepts United Therapeutics' resubmitted NDA for Tyvaso DPI as Class 1 review; target date Feb 2022

## Summary
- FDA accepted resubmission of NDA for Tyvaso DPI as a Class 1 response after Complete Response Letter in Oct 2021.
- User fee goal date (PDUFA) set for February 2022, indicating expedited review.
- Tyvaso DPI is an inhaled treprostinil product for pulmonary arterial hypertension.
- Resubmission made on Dec 27, 2021, and accepted for review on Jan 18, 2022.

## SEC filing metadata
- accession: 0001104659-22-004549
- form_type: 8-K
- ticker: UTHR
- cik: 0001082554
- company_name: UNITED THERAPEUTICS Corp
- filed_at: 2022-01-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1082554/000110465922004549/0001104659-22-004549-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1082554/000110465922004549/tm223084d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-22-004549
- JSON: https://secwatch.observer/filing/0001104659-22-004549.json
- Plain text: https://secwatch.observer/filing/0001104659-22-004549.txt

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