US FDA's Label Updating Effort Needs Legislation To Impact Generics
Generic labels can't easily be changed if reference product is withdrawn, meaning legislative fix is needed to add current recommendations to outdated labels.
You may also be interested in...
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.
Oncology Center of Excellence is reviewing a research report on fluorouracil, and will next look to update cisplatin's label, but eventually must convince the reference product sponsor to submit the changes.
Updated drug pricing bill would allow US FDA to approve generics even if innovator safety information is protected by exclusivity.