FDA updates fludarabine phosphate labeling under Project Renewal
The agency approved revised labeling for Sandoz's fludarabine phosphate injection as part of an effort to refresh information on older cancer drugs.
On November 19, 2024, the FDA approved updated drug labeling for fludarabine phosphate (Fludarabine Phosphate Injection, Sandoz) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for certain older oncology drugs.1
The document does not provide further detail on what specific sections of the label were changed or the rationale behind the update beyond its inclusion in the Project Renewal initiative.
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