Prescription medicine
Valrubicin Brand names: Valstar
Valrubicin (Valstar) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the valrubicin FDA label on DailyMed (effective October 31, 2024, Endo USA, Inc.); the NDA 20892 record on Drugs@FDA; every valrubicin label on DailyMed.
Highlights of the record
FDA label of October 31, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVALSTAR 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.
Forms and strengths
- 40 mg/ml
Solution (concentrate).
On the market
- Earliest approval on file
- September 25, 1998 Valstar Preservative Free, Endo Operations; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first April 19, 2019; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 1 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 177 through July 30, 2026
What is valrubicin used for?
From the label: indications and usageVALSTAR 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. 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.
Source: FDA drug label (Valstar), Endo USA, Inc., effective October 31, 2024 (SPL set e96f30a0-6662-11de-8f80-0002a5d5c51b), via openFDA; the full label on DailyMed
Is there a generic for valrubicin (Valstar)?
The FDA approved the first generic valrubicin on April 19, 2019. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists valrubicin from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1998 earliest approval on file
- 2019 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the valrubicin label say about other medicines?
The valrubicin label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Castor oil | contraindications | CONTRAINDICATIONS VALSTAR is contraindicated in patients with: Perforated bladder [ see Warnings and Precautions ( 5.2 )] Known hypersensitivity to anthracyclines or polyoxyl castor oil Active urinary tract infection Small bladder capacity and unable to tolerate a 75 mL instillation Perforated bladder or compromised … |
Source: FDA drug label (Valstar), Endo USA, Inc., effective October 31, 2024 (SPL set e96f30a0-6662-11de-8f80-0002a5d5c51b), via openFDA; the full label on DailyMed
What do FAERS reports show for valrubicin?
The FDA Adverse Event Reporting System holds 177 reports that list valrubicin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 8 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Valrubicin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other