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Novo Nordisk Gets Approval For Hemophilia B Treatment Sans Postmarketing Requirements

 
• By Michael Cipriano

Rebinyn's approval without postmarketing requirements comes as a surprise, given the advisory committee's concerns that the proposed plans weren't robust enough, as well as concerns from FDA about the treatment's safety.

The US FDA has approved Novo Nordisk AS's hemophilia B biologic Rebinyn (nonacog beta pegol) without any postmarketing requirements.

Indicated for the treatment and control of bleeding episodes and the perioperative management of bleeding in adults and children with the disease, Rebinyn was approved following an April 4 meeting of the Blood Products Advisory Committee,

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