Sunday, July 26, 2026
Approved
approved Note: Approved 2026-09-25 as JUVMO (ORIG NDA220415). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 61d from the PDUFA date. MEDIUM match accepted by owner review 2026-10-06: it is the drug's first-ever (ORIG) approval, so it can only be this decision.
Drug Information
- Drug Name
- Tavapadon (CT.gov)
- Application Type
- NDA
- Indication
- Parkinson's disease (monotherapy and adjunct to levodopa)
- Approved As
- Tavapadon
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