Valrubicin

Sold as Valstar Preservative Free. Every FDA application for this active ingredient: 1 branded and 1 generic.

As of Nov 14, 2026, FDA lists 2 applications for Valrubicin (sold as Valstar Preservative Free), first approved Sep 25, 1998, with 1 new use approved and 0 published complete response letters.

First approved: Sep 25, 1998
Applications: 2
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $1.3M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Valrubicin	Part B	$1.3M	-37%	42

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of carcinoma in situ of the urinary bladder.Anthra Pharmaceuticals, Inc. · designated May 23, 1994 · approved Sep 25, 1998

Shortages

FDA's drug shortage list, as of Nov 13, 2026

Shortage	Status	First posted	Updated
Valrubicin Solution	To Be Discontinued	Nov 13, 2026	Nov 13, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Sep 25, 1998	Valstar Preservative FreeNDA 20892 · New molecular entity	Endo Operations	8	Marketed
Apr 19, 2019	ValrubicinANDA 206430	Hikma	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA