Treats relapsing forms of multiple sclerosis (MS). NDA 213498, held by Vanda Pharms Inc. Ponesimod.
As of Nov 13, 2026, NDA 213498 (Ponvory), held by Vanda Pharms Inc, was first approved by FDA on Mar 18, 2021, with 4 approved supplements and 0 published complete response letters.
PONVORY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 18, 2021 | Original applicationNew molecular entity · Standard review | Approved |
| Jun 5, 2024 | Supplement 5Labeling · Standard review | Approved | |
| Jun 5, 2024 | Supplement 6Labeling · Standard review | Approved | |
| Aug 10, 2023 | Supplement 4Labeling · Standard review | Approved | |
| Oct 28, 2021 | Supplement 1Labeling · Standard review | Approved | |
| Mar 18, 2021 | 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
