Products Affected - Description

• • Fludarabine intravenous solution for injection, Fresenius Kabi, 25 mg/mL, 2 mL vial, 1 count, NDC 63323-0192-02
  • Fludarabine intravenous lyophilized powder for injection, Leucadia Pharmaceuticals, 50 mg, vial, 1 count, NDC 24201-0237-01
  • Fludarabine intravenous, Pfizer, 50 mg, vial, 1 count, NDC 61703-0344-18 - discontinued
  • Fludarabine intravenous solution for injection, Sagent, 25 mg/mL, 2 mL vial, 1 count, NDC 25021-0242-02
  • Fludarabine intravenous lyophilized powder for injection, Teva, 50 mg, vial, 1 count, NDC 45963-0309-55
  • Fludarabine intravenous solution for injection, Teva, 25 mg/mL, 2 mL vial, 1 count, NDC 45963-0621-51

Reason for the Shortage

• • Areva did not provide a reason for the shortage.
  • Fresenius Kabi has fludarabine injection on shortage due to increased demand.
  • Leucadia did not provide a reason for the shortage.
  • Pfizer discontinued fludarabine in August 2020. Their estimated market share was less than 1%.
  • Sagent has fludarabine on shortage due to manufacturing delays.
  • Teva did not provide a reason for the shortage.

Available Products

• • Fludarabine intravenous solution for injection, Areva, 25 mg/mL, 2 mL vial, 1 count, NDC 59923-0604-02

• • Areva has fludarabine 25 mg/mL 2 mL vials available for direct orders only.
  • Fresenius Kabi has fludarabine 25 mg/mL 2 mL vials on back order and the company estimates a release date of mid- to late-April 2023. Emergency orders may be available for active patients. Call Fresenius Kabi customer service for information.
  • Leucadia has fludarabine lyophilized powder 50 mg vials temporarily unavailable and the company cannot estimate a release date.
  • Sagent has fludarabine 25 mg/mL 2 mL vials on back order and the company estimates a release date of June 2023.
  • Teva has fludarabine 25 mg/mL 2 mL vials temporarily unavailable and the company cannot estimate a release date. The lyophilized powder 50 mg vials are on allocation.