Rebinyn Approval History

• FDA approved: Yes (First approved May 31st, 2017)
• Brand name: Rebinyn
• Generic name: coagulation factor IX (recombinant), glycopegylated
• Dosage form: Injection
• Company: Novo Nordisk
• Treatment for: Hemophilia B

Rebinyn (coagulation factor IX (recombinant), glycopegylated is an extended-half-life recombinant DNA-derived coagulation factor IX concentrate for the treatment and control of bleeding episodes in patients with hemophilia B.

Development History and FDA Approval Process for Rebinyn

Date	Article
May 31, 2017	FDA Approves Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) for Patients with Hemophilia B
Apr  4, 2017	FDA Advisory Committee Discusses Biologics License Application (BLA) for Nonacog Beta Pegol for the Treatment of People with Hemophilia B

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