4/8/2024

Streptozocin Injection

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.
- The company contact is: [email protected]

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.

Disclaimer

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