Quick answers
- What is Alitretinoin used for?
- The FDA-approved label (Panretin, Advanz Pharma (US) Corp., November 25, 2025) says: “Kaposi’s Sarcoma PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS). Limitations of Use: PANRETIN GEL is not indicated when systemic anti-KS therapy is required (including more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement) […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Alitretinoin have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Alitretinoin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Alitretinoin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Alitretinoin?
- 1 company lists prescription products of Alitretinoin in the FDA NDC Directory, including Advanz Pharma (US) Corp..
What Alitretinoin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Kaposi’s Sarcoma PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS). Limitations of Use: PANRETIN GEL is not indicated when systemic anti-KS therapy is required (including more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement) […]. …
— FDA label: Panretin, Advanz Pharma (US) Corp., effective November 25, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
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.
Forms and how it is given
| Dosage forms | Gel |
|---|---|
| Route | Topical |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Panretin |
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.
- Advanz Pharma (US) Corp.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020886 PANRETIN | Advanz Pharma | February 2, 1999 | 4, latest November 17, 2025 2025: Labeling · 2013: Manufacturing (CMC) · 2000: Manufacturing (CMC) |
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
| RxCUI (RxNorm) | 213502, 313847 |
|---|---|
| SPL set ID of the quoted label | 49c16717-7d86-4257-80c9-baa1417e5555 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA020886 |
| Active ingredients (FDA) | ALITRETINOIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Panretin, Advanz Pharma (US) Corp., effective November 25, 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 →