Sunday, July 26, 2026
Approved May 27, 2026
approved Note: NDA submitted Sep 26, 2025. PDUFA estimated at 10 months (standard review). D1/D5 partial agonist.
Drug Information
- Drug Name
- Tavapadon (CT.gov)
- Application Type
- NDA
- Indication
- Parkinson's disease (monotherapy and adjunct to levodopa)
- Approved As
- DECNUPAZ →
Filing Details
- Company
- AbbVie Inc. →
- Stock Ticker
- ABBV
- SEC CIK
- 0001551152
- Source
- Company IR →
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
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Data sourced from SEC EDGAR filings. Last updated: 2026-04-20. Report an issue