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 |
|
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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