Foundayo (orforglipron calcium)
New molecular entity
- Region
- 🇺🇸 US
- Active substance
- orforglipron calcium
- Company
- Eli Lilly And Co
- Status
- Approved
- FDA approval
- Wed 01 Apr 2026
- Designations
- New molecular entity
- Application
- NDA220934
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Mon 21 Dec 2026🇪🇺 Expected EC decisionestimate
Foundayo (Orforglipron): expected EC decision
Estimated as CHMP opinion (2026-10-15) + 67 days, the standard Commission decision period. Not an official date. · Eli Lilly Nederland B.V. · source
Thu 15 Oct 2026🇪🇺 CHMP positive opinion
Foundayo (Orforglipron): CHMP positive opinion
Wed 01 Apr 2026🇺🇸 FDA approval
FDA approves Foundayo (orforglipron calcium), a new medicine
Eli Lilly And Co; NDA220934; New molecular entity; tablet · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.