FDAsafety guidance77% confidence
FDA AP — TYVASO (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as United Therapeutics; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA022387. Sponsor: UNITED THERAP. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: TREPROSTINIL.
Supporting Context
- Therapeutic area
- Pulmonary Arterial Hypertension · Prostacyclin Analog
- Sub-indication
- Hypertension
Related signal: FDA Accepts Supplement Application for Tyvaso (Treprostinil)