Quick answers
- What is Valrubicin intravesical solution used for?
- The FDA-approved label (Valstar, Endo USA, Inc., October 31, 2024) says: “VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Valrubicin intravesical solution 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 Valrubicin intravesical solution?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Valrubicin intravesical solution been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Valrubicin intravesical solution?
- 2 companies list prescription products of Valrubicin intravesical solution in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc. and Endo USA, Inc..
What Valrubicin intravesical solution is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. …
— FDA label: Valstar, Endo USA, Inc., effective October 31, 2024. 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.
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 | Solution, concentrate |
|---|---|
| Route | Intravesical |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Valstar |
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.
- Hikma Pharmaceuticals USA Inc.1 product
- Endo USA, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020892 VALSTAR PRESERVATIVE FREE | Endo Operations | September 25, 1998 | 8, latest April 7, 2016 2016: Labeling · 2014: Manufacturing (CMC) · 2013: Manufacturing (CMC) |
Generic approvals (1)
- ANDA206430Hikma · April 19, 2019
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) | 262063, 313567 |
|---|---|
| SPL set ID of the quoted label | e96f30a0-6662-11de-8f80-0002a5d5c51b |
| FDA labels (SPL) | 2 |
| FDA applications | NDA020892, 1 ANDA |
| Active ingredients (FDA) | VALRUBICIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Valstar, Endo USA, Inc., effective October 31, 2024; 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 →