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