FDAapproval95% confidence
GDUFA III Enhancements to the Pre-ANDA Program
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
The Pre-ANDA Program is designed to assist prospective generic drug applicants in developing more complete submissions, promote a more efficient and effective ANDA assessment process, reduce the number of assessment cycles, and facilitate approval of complex generic drug products.
Supporting Context
- Therapeutic area
- Nephrology · Drug
- Sub-indication
- General
Related signal: FDA Accepts Supplemental NDA for Travere's Filspari (Sparsentan)