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Coagulation Factor Ix News

FDA Approves Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) for Patients with Hemophilia B

Posted 27 Jun 2017 by Drugs.com

PLAINSBORO, N.J., May 31, 2017 /PRNewswire/ – Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) for the treatment of adults and children with hemophilia B. Hemophilia B is a chronic and inherited bleeding disorder that affects approximately 5,000 people in ...

Idelvion Approved for Hemophilia B

Posted 8 Mar 2016 by Drugs.com

MONDAY, March 7, 2016 – Idelvion has been approved by the U.S. Food and Drug Administration to replace a deficient blood clotting factor among people with hemophilia B. The product – which has the generic name of "coagulation Factor IX, albumin fusion protein" – is created using recombinant DNA technology that links the blood clotting protein known as Factor IX to another blood protein, ...

FDA Approves Idelvion (coagulation factor IX (recombinant), albumin fusion protein) to Treat Patients with Hemophilia B

Posted 8 Mar 2016 by Drugs.com

March 4, 2016 – The U.S. Food and Drug Administration today approved Idelvion, Coagulation Factor IX (Recombinant), Albumin Fusion Protein, for use in children and adults with Hemophilia B. Idelvion is the first coagulation factor-albumin fusion protein product to be approved, and the second Factor IX fusion protein product approved in the U.S. that is modified to last longer in the blood. “The ...

Emergent BioSolutions Announces FDA Approval of Ixinity [coagulation factor IX (recombinant)] for Hemophilia B

Posted 1 May 2015 by Drugs.com

GAITHERSBURG, Md., April 30, 2015 (GLOBE NEWSWIRE) – Emergent BioSolutions Inc. (NYSE:EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved Ixinity [coagulation factor IX (recombinant)], an intravenous recombinant human coagulation factor IX therapeutic for the control and prevention of bleeding episodes and for perioperative management in adults and children, ≥12 y ...

Long-Acting Clotting Agent Alprolix Approved for Form of Hemophilia

Posted 31 Mar 2014 by Drugs.com

MONDAY, March 31, 2014 The drug Alprolix has been approved by the U.S. Food and Drug Administration as the first long-acting hemophilia B clotting agent, the FDA said in a news release. The product, formally known as "coagulation factor IX recombinant Fc Fusion protein" is the first hemophilia B remedy designed to require less frequent injections than prior treatments, the FDA said. It was ...

FDA Approves Rixubis - First Recombinant Coagulation Factor IX For Use in Preventing Bleeding Episodes

Posted 27 Jun 2013 by Drugs.com

June 27, 2013 – The U.S. Food and Drug Administration yesterday approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older. Rixubis is indicated for the control and prevention of bleeding episodes, perioperative (period extending from the time of hospitalization for surgery to the time of discharge) management, and routine use to ...

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Further Information

Related Condition Support Groups

Hemophilia B, Factor IX Deficiency

Related Drug Support Groups

Rixubis, Idelvion, Alprolix, Ixinity, Mononine, BeneFix, BeneFIX 250 Int'l Units, Alphanine SD, Rebinyn

Coagulation Factor Ix Patient Information at Drugs.com