ALDVI
Sibnayal (ADV7103; potassium citrate / potassium bicarbonate)
FDA PDUFA Target Action Date · Advicenne SA
Thursday, September 3, 2026
Withdrawn
withdrawn Note: Advicenne voluntarily withdrew the US NDA on 2026-08-31: additional CMC work could not be completed within the current review cycle. Source: Advicenne press release https://ca.finance.yahoo.com/news/advicenne-decides-withdraw-adv7103-drug-050000148.html
Drug Information
- Application Type
- NDA
- Indication
- Distal renal tubular acidosis (dRTA)
- Approved As
- Sibnayal (ADV7103; potassium citrate / potassium bicarbonate)
Filing Details
- Company
- Advicenne SA
- Stock Ticker
- ALDVI
- Source
- Company press release →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-08-02. Report an issue