NDA 20892, held by Endo Operations. Valrubicin.
As of Nov 14, 2026, NDA 20892 (Valstar Preservative Free), held by Endo Operations, was first approved by FDA on Sep 25, 1998, with 8 approved supplements and 0 published complete response letters.
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.
| Aug 2, 2013 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Sep 25, 1998 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Valstar Preservative Free40MG/ML · solution;intravesical | Valrubicin | RxReference drug |
| Apr 7, 2016 | Supplement 19Labeling · Standard review | Approved | |
| Jan 17, 2014 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Nov 12, 2013 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Aug 2, 2013 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Dec 20, 2012 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Nov 2, 2011 | Supplement 13Labeling | Approved | |
| Apr 24, 2001 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Aug 5, 1999 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Sep 25, 1998 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
