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Rebinyn Approval History

FDA Approved: Yes (First approved May 31, 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

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

Further information

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