Quick answers
- Is there a shortage of Palovarotene?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated August 31, 2026). Ask your pharmacist about alternatives.
- Has Palovarotene been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Palovarotene?
- 1 company lists prescription products of Palovarotene in the FDA NDC Directory, including Ipsen Biopharmaceuticals, Inc..
What Palovarotene is used for
We did not find an “Indications and Usage” section in the FDA labels for this medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 5 in the FDA NDC Directory |
| Brand names | Sohonos |
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.
- Ipsen Biopharmaceuticals, Inc.5 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA215559 SOHONOS | Ipsen | August 16, 2023 | 2, latest September 18, 2026 2026: Labeling · 2025: Efficacy |
Shortage status
To be discontinued · updated August 31, 2026 · first posted August 31, 2026
| Product | SOHONOS, Capsule, 2.5 mg (NDC 15054-0025-1) |
|---|---|
| Company | Ipsen Biopharmaceuticals, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| FDA labels (SPL) | 0 |
|---|---|
| FDA applications | NDA215559 |
| Active ingredients (FDA) | PALOVAROTENE |
Sources
- 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 →