FDA approves updated drug labelling including new indications and dosing regimens for capecitabine tablets under Project Renewal

FDA

14 December 2022 - Today, the FDA approved updated labelling for capecitabine tablets (Xeloda, Genentech) under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labelling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. 

This is the first drug to receive a labelling update under this pilot program.

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Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US