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

• • Teva has Zanosar injection on back order and no future production is expected for an extended period.

• • 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]