Quick answers
- What is Ponesimod used for?
- The FDA-approved label (Ponvory, Vanda Pharmaceuticals Inc., December 4, 2025) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ponesimod have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ponesimod?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ponesimod been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ponesimod?
- 2 companies list prescription products of Ponesimod in the FDA NDC Directory, including Janssen Pharmaceuticals, Inc. and Vanda Pharmaceuticals Inc..
What Ponesimod is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Ponvory, Vanda Pharmaceuticals Inc., effective December 4, 2025. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Ponvory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Janssen Pharmaceuticals, Inc.1 product
- Vanda Pharmaceuticals Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA213498 PONVORY | Vanda Pharms Inc | March 18, 2021 | 4, latest June 5, 2024 2024: Labeling · 2024: Labeling · 2023: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ponvory, Vanda Pharmaceuticals Inc., effective December 4, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →