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Takeda Pharmaceuticals USA Inc.

Division of Takeda Pharmaceutical Co. Ltd.
www.tpna.com

Latest From Takeda Pharmaceuticals USA Inc.

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

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.

Drug Safety Post Market Regulation & Studies

Can A REMS Mitigate CV Risks? Avandia, Meridia Offer Point, Counterpoint

As US FDA weighs fate of Takeda’s febuxostat, advisory committee members suggest REMS to ensure prescribers have informed benefit/risk conversation with patients, but agency staff highlight design and assessment challenges for such a program.

Advisory Committees Drug Safety

Is There A REMS In Uloric’s Future? US FDA Panelists Say Yes, Agency Says Not Likely

Continued availability of Takeda’s febuxostat should be restricted to second-line use in gout patients who cannot tolerate or fail allopurinol, advisory committee majority says, opposing market withdrawal; but panelists’ suggestion that a Risk Evaluation and Mitigation Strategy be put in place to ensure patients and prescribers discuss cardiovascular risks receives pushback from agency.

Advisory Committees Drug Safety

Takeda’s Uloric: CV Mortality Signal Leads US FDA To Ponder Regulatory Options

Advisory committee will discuss whether CARES postmarketing trial showing 34% increased risk of cardiovascular death for febuxostat warrants market withdrawal, use restrictions, or new labeling for the gout drug.

Advisory Committees Drug Safety
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Company Information

  • Industry
  • Pharmaceuticals
  • Therapeutic Areas
  • Non-Specific
  • Alias(es)
  • Takeda Pharmaceuticals North America Inc.
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Takeda Pharmaceutical Co. Ltd.
  • Senior Management
  • Ramona Sequeira, Pres.
  • Contact Info
  • Takeda Pharmaceuticals USA Inc.
    Phone: (224) 554-6500
    One Takeda Parkway
    Deerfield, IL 60015
    USA
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