Biologics Approved In 2013

FDA transferred review of most therapeutic biologics to the Center for Drug Evaluation & Research in 2003. The Center for Biologics Evaluation & Research continues to review other biologics, including vaccines, cellular products, antitoxins and immunoglobulins.

Product & Sponsor	Indication	Date Approved (Application Number)
Flublok* Influenza vaccine Protein Sciences Corp.	Trivalent insect cell (baculovirus)-expressed recombinant hemagglutinin vaccine for active immunization of persons aged 18 to 49 years old against disease caused by influenza virus subtypes A and B contained in the vaccine	1/16/2013 (125285)
Octaplas* Pooled plasma (human), solvent/detergent treated Octapharma Pharmazeutika	Solvent/detergent-treated pooled plasma for replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease and in patients undergoing cardiac surgery or liver transplantation and for plasma exchange in patients with thrombotic thrombocytopenic purpura	1/17/2013 (125416)
Kadcyla Ado-trastuzumab emtansine Genentech Inc.	HER-targeted antibody and mictrotubule inhibitor conjugate for single-agent treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab (Genentech’s Herceptin) and a taxane, separately or in combination	2/22/2013 (125427) (P)
BAT* Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine) Cangene Corporation	Mixture of immune globulin fragments derived from horse plasma for treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F or G in adult and pediatric patients	3/22/2013 (125462)
Kcentra* Prothrombin complex concentrate (human) CSL Behring	Human prothrombin complex concentrate derived from pooled plasma for urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g. warfarin) therapy in adult patients with acute major bleeding	4/29/2013 (125421)
Rixubis* Coagulation Factor IX (recombinant) Baxter Healthcare Corporation	Recombinant Coagulation Factor IX for use in adults with hemophilia B to control and prevent bleeding episodes, for perioperative management, and for routine prophylaxis to prevent or reduce the frequency of bleeding episodes	6/26/2013 (125446) (V)
NovoEight* Turoctocog alfa Antihemophilic Factor (recombinant) Novo Nordisk	Recombinant analog of human coagulation factor VIII with a truncated B-domain for treatment of adults and children with hemophilia A for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes	10/15/2013 (125466)
Gazyva Obinutuzumab Genentech	CD20-directed cytolytic antibody for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia	11/1/2013 (125486) (P, B)
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted GlaxoSmithKline	Vaccine for prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine, to be used in persons 18 years of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine	11/22/2013 (125419)
Tretten Catridecacog Novo Nordisk	Recombinant coagulation Factor XIII as an alternative to FXIII derived from human plasma as once-monthly replacement therapy for prophylaxis of bleeding episodes in patients with congenital FXIII A-subunit deficiency	12/23/2013 (125398)
S: Standard Review P: Priority Review V: Orphan Drug H: Accelerated Approval B: Breakthrough Therapy Products approved by CBER are designated with an asterisk (*).