Treats endogenous hypercortisolemia. NDA 212801, held by Recordati Rare. Osilodrostat Phosphate.
As of Nov 13, 2026, NDA 212801 (Isturisa), held by Recordati Rare, was first approved by FDA on Mar 6, 2020, with 3 approved supplements and 0 published complete response letters.
ISTURISA is indicated for the treatment of endogenous hypercortisolemia in adults with Cushing's syndrome for whom surgery is not an option or has not been curative.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 3, 2025 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Apr 15, 2025 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Mar 6, 2020 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| IsturisaEQ 1MG BASE · tablet;oral | Osilodrostat Phosphate | RxReference drug |
| IsturisaEQ 5MG BASE · tablet;oral | Osilodrostat Phosphate | RxReference drug |
| IsturisaEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Osilodrostat Phosphate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 4, 2025 | Supplement 7Manufacturing | Approved | |
| Jul 3, 2025 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Apr 15, 2025 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Mar 6, 2020 | 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
