For progressing desmoid tumors. NDA 217677, held by Springworks. Nirogacestat Hydrobromide.
As of Nov 13, 2026, NDA 217677 (Ogsiveo), held by Springworks, was first approved by FDA on Nov 27, 2023, with 4 approved supplements and 0 published complete response letters.
OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 27, 2023 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| OgsiveoEQ 50MG BASE · tablet;oral | Nirogacestat Hydrobromide | DiscontinuedReference drug |
| OgsiveoEQ 100MG BASE · tablet;oral | Nirogacestat Hydrobromide | RxReference drug |
| OgsiveoEQ 150MG BASE · tablet;oral | Nirogacestat Hydrobromide | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 20, 2026 | Supplement 9Labeling · Standard review | Approved | |
| Jul 17, 2026 | Supplement 8Labeling · Standard review | Approved | |
| Mar 10, 2026 | Supplement 6Labeling · Standard review | Approved | |
| Apr 4, 2024 | Supplement 1Manufacturing | Approved | |
| Nov 27, 2023 | Original applicationNew molecular entity · Priority 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
