Genentech’s Xeloda Is First Label Updated Under OCE’s ‘Project Renewal’
Capecitabine’s existing indications were revised and new indications added, reflecting uses that long have been considered standard of care; however, the cancer drug's label had been frozen in time since the approval of generics.
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FDA is most often thought of as a regulator of off-label communication, but a new citizen petition on a contentious topic highlights the murkiness of the agency’s own obligations to discuss unapproved uses of drugs – particularly when effectiveness comes into play – and the challenges when medicine use becomes politically polarized.
Takeda’s TAK-721 is back, ARS Pharma will be back soon to appeal neffy complete response letter, US FDA’s Project Renewal brings Temodar labeling in current day, and more highlights from the Pink Sheet’s US FDA Performance Tracker.
US FDA-related legislation among the bills moving during the lame duck session of Congress.