Wednesday, January 20, 2027
Approved
approved Note: Approved April 1, 2026 — 294 days before PDUFA date via National Priority Voucher Program. First oral GLP-1 for weight loss.
Drug Information
- Drug Name
- Foundayo (orforglipron) (CT.gov)
- Application Type
- NDA
- Indication
- Chronic weight management in adults with obesity or overweight
Filing Details
- Company
- Eli Lilly and Company →
- Stock Ticker
- LLY
- SEC CIK
- 0000059478
- 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