FDAapproval95% confidence
GDUFA III Controlled Correspondence Enhancements
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable approval decision relevant to Travere Therapeutics; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Controlled correspondence is a correspondence submitted to FDA by or on behalf of a generic drug manufacturer or related industry requesting information on a specific element of generic drug product development or concerning certain post-approval submission requirements.
Supporting Context
- Therapeutic area
- Nephrology · Drug
- Sub-indication
- General
Related signal: FDA Accepts Supplemental NDA for Travere's Filspari (Sparsentan)