Streptozocin Injection Shortage
Last Updated: April 8, 2024
Status: Current
Products Affected - Description
-
- Zanosar powder for solution for injection, Teva, 1 gram, vial, 1 count, NDC 00703-4636-01
Reason for the Shortage
-
- Teva closed a manufacturing facility in Irvine, California, in late-2021 in response to FDA concerns about contamination issues.
Available Products
-
- Imported non-FDA-approved Zanosar 1 gram vials, Marketing Authorization Number: PL 40308-0001
Estimated Resupply Dates
-
- Teva has Zanosar injection on back order and no future production is expected for an extended period.
Alternative Agents & Management
-
- FDA is allowing temporary importation of non-FDA-approved Zanosar from Esteve Pharmaceutical SAS. The dosage schedules and therapeutic indications are the same for the imported and US approved Zanosar. There are key differences including shelf-life, indication, administration, and reconstitution. Detailed information can be found at: https://www.fda.gov/media/166810/download
- The imported Zanosar does not have an NDC number and its bar code may not be compatible with US scanning systems.
- The packaging may have Keocyt listed as the supplier. This is the same company as Esteve Pharmaceuticals SAS, it just had a name change in 2022.
Updated
Updated April 8, 2024 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 27, 2022 by Leslie Jensen, PharmD, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.