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Takeda’s Uloric Gets CV Death Warning And Restricted Indication, But No REMS

 
• By Sue Sutter

Despite advisory committee pressure, US FDA stands firm against imposing REMS targeted at gout drug’s cardiovascular risks; however, Takeda must conduct utilization study to see if labeling changes impact prescribing patterns.

Wood chopping with hand axe

The US FDA split the difference with its external advisors on the regulatory options for Takeda Pharmaceuticals USA Inc.’s gout drug Uloric (febuxostat), requiring the cardiovascular death label warning and restricted indication advocated by its advisory committee but not the formal Risk Evaluation and Mitigation Strategy (REMS) that agency staff suggested was unworkable.

Nevertheless, the regulatory actions highlighted by FDA, including a new postmarketing commitment by Takeda to monitor febuxostat utilization after the strengthened labeling is implemented, seem aimed at

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