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Transfer of Therapeutic Products
to the Center for Drug Evaluation and Research

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Approved Products Transferring to CDER

Product Name Proprietary Name Applicant Name
Abciximab ReoPro Centocor B.V.
Adalimumab Humira Abbott Laboratories
Agalsidase beta Fabrazyme Genzyme Corp
Aldesleukin Proleukin Chiron Corp
Alefacept Amevive Biogen, Inc
Alemtuzumab Campath ILEX Pharmaceuticals L.P.
Alteplase Activase Genentech, Inc
Anakinra Kineret Amgen, Inc
Anistreplase Eminase Wulfing Pharma GmbH
Arcitumomab CEA-Scan Immunomedics, Inc
Asparaginase Elspar Merck & Co., Inc
Basiliximab Simulect Novartis Pharmaceuticals Corp
Becaplermin Regranex OMJ Pharmaceuticals, Inc
Becaplermin Concentrate   Chiron Corp
Botulinum Toxin Type A BOTOX
BOTOX COSMETIC
Allergan, Inc
Botulinum Toxin Type B MYOBLOC Elan Pharmaceuticals
Capromab Pendetide ProstaScint Cytogen Corp
Collagenase Santyl Advance Biofactures Corp
Daclizumab Zenapax Hoffmann-La Roche Inc
Darbepoetin alfa Aranesp Amgen, Inc
Denileukin diftitox Ontak Seragen, Inc
Dornase alfa Pulmozyme Genentech, Inc
Drotrecogin alfa (Activated) Xigris Eli Lilly & Co
Epoetin alfa Epogen Amgen, Inc
Epoetin alfa Eprex Ortho Biologics LLC
Etanercept Enbrel Immunex Corp
Filgrastim Neupogen Amgen, Inc
Ibritumomab tiuxetan Zevalin IDEC Pharmaceuticals Corp
Indium In-111 Chloride Sterile Solution Indium In-111 Chloride Sterile Solution Mallinckrodt Medical, Inc
Indium In-111 Chloride Sterile Solution Indiclor Medi-Physics, Inc
Infliximab Remicade Centocor, Inc
Interferon alfa-2a Roferon A Hoffmann-La Roche Inc
Interferon alfa-2b Intron A Schering Corp
Interferon alfacon-1 Infergen InterMune, Inc
Interferon alfa-n3 (Human Leukocyte Derived) Alferon N Injection Interferon Sciences, Inc
Interferon beta-1a Avonex Biogen, Inc
Interferon beta-1a Rebif Serono, Inc
Interferon beta-1b Betaseron Chiron Corp
Interferon gamma-1b Actimmune InterMune, Inc
Laronidase Aldurazyme Biomarin Pharmaceutical Inc
Muromonab-CD3 Orthoclone OKT3 Ortho Biotech Products, LP
Nofetumomab Verluma Boehringer Ingelheim Pharma KG
Omalizumab Xolair Genentech, Inc
Oprelvekin Neumega Genetics Institute, Inc
Palivizumab Synagis MedImmune, Inc
Pegaspargase Oncaspar Enzon, Inc
Pegfilgrastim Neulasta Amgen, Inc
Peginterferon alfa-2a Pegasys Hoffman-La Roche Inc
Peginterferon alfa-2b PEG-Intron Schering Corp
Rasburicase Elitek Sanofi-Synthelabo, Inc
Reteplase Retavase Centocor, Inc
Rituximab Rituxan Genentech, Inc
Rituximab Formulated Bulk (For Further Manufacturing Use)   IDEC Pharmaceuticals Corp
Sargramostim Leukine Berlex Laboratories, Inc
Satumomab Concentrate (For Further Manufacturing Use)   LONZA Biologics plc
Satumomab Pendetide OncoScint CR/OV Cytogen Corp
Streptokinase Streptase Aventis Behring GmbH
Tenecteplase TNKase Genentech, Inc
Tositumomab and Iodine I 131 Tositumomab Bexxar Corixa Corp
Trastuzumab Herceptin Genentech, Inc
Urokinase Abbokinase Abbott Laboratories - Pharmaceutical Products Division

 

 
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