Project Renewal
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Project Renewal is a public health initiative established by the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) that aims to update the prescribing information (i.e., labeling) for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date.
With new information available in the post-marketing setting, certain older oncology drugs on the market today may include outdated information. Patients and healthcare providers rely on accurate information for care and treatment decisions. Aligned with the FDA’s mission to protect public health, this initiative evaluates publicly available scientific evidence to update prescribing and patient information necessary for safe and effective use of these drugs. Project Renewal also provides an opportunity to engage with the oncology community to improve awareness of FDA drug labeling as an information resource.
Project Renewal is working to address this public health challenge by establishing a set of processes and procedures to inform regulatory decisions and update indications for use, dosage and administration, and other clinically significant information. As an extended part of the program, Project Renewal is also leveraging its experience from oncology to update labeling of older drugs in other disease areas.
Project Renewal Approvals
| Drug Name | Approval Date | Additional Resources |
| Fludarabine Phosphate | November 19, 2024 | |
| Temodar (temozolomide) | September 14, 2023 | |
| Xeloda (capecitabine) | December 14, 2022 |