For obesity or adults with overweight in the presence of at least one weight-related…. NDA 220934, held by Eli Lilly And Co. Orforglipron Calcium.
As of Nov 14, 2026, NDA 220934 (Foundayo), held by Eli Lilly And Co, was first approved by FDA on Apr 1, 2026, with 1 approved supplement and 0 published complete response letters.
FOUNDAYO TM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 1, 2026 | Original applicationNew molecular entity · Standard review | Approved |
| FoundayoEQ 0.8MG BASE · tablet;oral | Orforglipron Calcium | RxReference drug |
| FoundayoEQ 2.5MG BASE · tablet;oral | Orforglipron Calcium | RxReference drug |
| FoundayoEQ 5.5MG BASE · tablet;oral | Orforglipron Calcium | RxReference drug |
| FoundayoEQ 9MG BASE · tablet;oral | Orforglipron Calcium | RxReference drug |
| FoundayoEQ 14.5MG BASE · tablet;oral | Orforglipron Calcium | RxReference drug |
| FoundayoEQ 17.2MG BASE · tablet;oral | Orforglipron Calcium | RxReference drug |
| Aug 4, 2026 | Supplement 3Labeling · Standard review | Approved | |
| Apr 1, 2026 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
