Overview
- FDA instructions, posted Tuesday in an approval letter signed April 1, direct Eli Lilly to study drug‑induced liver injury, major heart events, and delayed stomach emptying linked to Foundayo.
- Lilly must run an ultrasound study to measure retained gastric contents after dosing pauses and different fasting periods to probe delayed stomach emptying.
- The agency also requires a milk‑only lactation study, a pregnancy registry, a pediatric registry, and at least 15 years of thyroid cancer monitoring.
- Foundayo won clearance earlier this month under a pilot voucher that speeds reviews and is already on sale, and Lilly says the post‑approval demands are routine.
- The pill uses orforglipron, a newer non‑peptide GLP‑1 with less long‑term data than semaglutide in Novo Nordisk’s oral Wegovy, which faced fewer post‑approval requests.