Streptozocin Injection Shortage

• • Zanosar powder for solution for injection, Teva, 1 gram, vial, 1 count, NDC 00703-4636-01

• • Teva closed a manufacturing facility in Irvine, California, in late-2021 in response to FDA concerns about contamination issues.

• • 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.
  • Please keep in mind that the company is not storing streptozocin within the U.S., so each order will be shipped straight to the institution requesting it. With that in mind, they recommend that you order what you anticipate you may need for a 4-6 month period.