> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Fludarabine Phosphate Labeling Changes OKd
- URL: https://www.fdaweb.com/fludarabine-phosphate-labeling-changes-okd/
- Published: 2024-11-20T12:00:00.000Z
- Updated: 2026-09-14T14:47:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158228

FDA has used the Oncology Center of Excellence’s Project Renewal to approve labeling changes for Sandoz’ fludarabine phosphate cancer drug injection. An agency [announcement](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-updated-drug-labeling-fludarabine-phosphate-under-project-renewal?source=email) says this is the third drug to receive a Project Renewal labeling update. Project Renewal is aimed at updating labeling information for certain older oncology drugs to ensure the information is clinically meaningful and scientifically up to date.

The statement says the injection is now approved for these new and revised indications:

- as a component of a combination regimen to treat adults with B-cell chronic lymphocyte leukemia; and
- to treat adults with B-cell chronic lymphocyte leukemia who have not responded to or whose disease has progressed during treatment with at least one alkylating-agent-containing regimen.

Additional labeling revisions, it says, include:

- revised and updated dosage regimen to include the recommended dosage for use in combination with cyclophosphamide and rituximab; and
- removal of the Boxed Warning and incorporation of its information in the Warnings and Precautions section.