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Therapeutic Biological Products
On October 1, 2003, FDA transferred certain product oversight
responsibilities from the Center for Biologics Evaluation and
Research (CBER) to the Center for Drug Evaluation and Research
(CDER). This consolidation provides greater opportunities to further
develop and coordinate scientific and regulatory activities between
CBER and CDER, leading to a more efficient, effective, and
consistent review program for human drugs and biologics. FDA
believes that as more drug and biological products are developed for
a broader range of illnesses, such interaction is necessary for both
efficient and consistent agency action. Under the new structure, the
biologic products transferred to CDER will continue to be regulated
as licensed biologics.
To
see which product classes have been transferred and which will
remain at CBER, please refer to Transfer
of Therapeutic Products to the Center for Drug Evaluation and
Research.
The therapeutic biological products now under CDER's review
include:
- Monoclonal antibodies for in-vivo use
- Cytokines, growth factors, enzymes, immunomodulators; and
thrombolytics
- Proteins intended for therapeutic use that are extracted
from animals or microorganisms, including recombinant versions
of these products (except clotting factors)
- Other non-vaccine therapeutic immunotherapies
OFFICE OF DRUG EVALUATION I |
RESPONSIBLE OFFICE/DIVISION |
INDICATION |
PRODUCT |
Division of Cardiovascular and Renal Products |
Renal Disorders Cardiology Disorders Arterial Vascular Disorders
|
Activase [Alteplase]
Cathflo Activase [Alteplase]
ReoPro [Abciximab]
Retavase [Reteplase]
Streptase [Streptokinase]
TNKase [Tenecteplase]
|
Division of Neurology Products |
Neurology Peripheral neuropathy (not intrinsically painful neuropathies)
|
Avonex [Interferon beta-1a]
Betaseron [Interferon beta-1b]
Botox [Botulinum Toxin Type A]
Myobloc [Botulinum Toxin Type B]
Rebif [Interferon beta-1a]
Tysabri [Natalizumab]
|
Division of Psychiatry Products |
----------------- |
----------------- |
OFFICE OF DRUG EVALUATION II |
RESPONSIBLE OFFICE/DIVISION |
INDICATION |
PRODUCT |
Division of Metabolism and Endocrinology Products |
Endocrine
Bone related (osteoporosis, surgery and other bone repair)
|
----------------- |
Division of Pulmonary and Allergy Products |
Allergy
Pulmonary
|
Pulmozyme [Dornase alfa]
Xolair [Omalizumab]
|
Division of Anesthesia, Analgesia and Rheumatology Products |
Rheumatology
Pain treatment (including peripheral neuropathies that are intrinsically painful)
|
Enbrel [Etanercept]
Humira TM [Adalimumab]
Kineret [Anakinra]
Orencia [Abatacept]
Remicade [Infliximab]
|
OFFICE OF DRUG EVALUATION III |
RESPONSIBLE OFFICE/DIVISION |
INDICATION |
PRODUCT |
Division of Reproductive and Urologic Products |
Urologic
Reproductive
|
----------------- |
Division of Gastroenterology Products |
Gastrointestinal (includes non-viral hepatic disorders) Genetic metabolic (inborn) disorders
Large volume parenterals
|
Aldurazyme [Laronidase]
Fabrazyme [Agalsidase beta]
Naglazyme [Galsulfase]
|
Division of Dermatology and Dental Products |
Dental
Dermatology
|
Alferon N Injection [Interferon alfa-n3]
Amevive [Alefacept]
Raptiva [Efalizumab]
Regranex [Becaplermin]
Santyl [Collagenase]
|
OFFICE OF ANTIMICROBIAL PRODUCTS |
RESPONSIBLE OFFICE/DIVISION |
INDICATION |
PRODUCT |
Division of Anti-Infective and Ophthalmology Products |
Bacterial infectious disease Sepsis
Ophthalmology
|
Xigris [Drotrecogin alfa (activated)] |
Division of Special Pathogen and Transplant Products |
Solid organ transplant Immunodeficiency white cell disorders
Special pathogens (e.g., fungal, TB, Anthrax)
|
Actimmune [Interferon gamma-1b]
Orthoclone [Muromonab-CD3]
Simulect [Basiliximab]
Zenapax [Daclizumab]
|
Division of Antiviral Products |
Viral infections, including viral hepatitis |
Copasys Copegus [Peginterferon alfa-2a]
Infergen [Interferon alfacon-1]
Intron A [Interferon alfa-2b]
Pegasys [Peginterferon alfa-2a]
Peg-Intron [Peginterferon alfa-2b]
Roferon-A [Interferon alfa-2a]
Synagis [Palivizumab]
|
OFFICE OF ONCOLOGY DRUG PRODUCTS |
RESPONSIBLE OFFICE/DIVISION |
INDICATION |
PRODUCT |
Division of Drug Oncology Products |
All small molecule cancer treatments
Consolidated from many different divisions
Cancer Prevention
|
----------------- |
Division of Biologic Oncology Products |
Biologic cancer treatments Biologic cancer ancillary treatments
All biologics for GVHD (all cause transplants)
|
Avastin [Bevacizumab]
Bexxar [Tositumomab]
Campath [Alemtuzumab]
Elitek [Rasburicase]
Elspar [Asparaginase]
Eribitux [Cetuximab]
Herceptin [Trastuzumab]
Kepivance [Palifermin]
Leukine [Sargramostim]
Neulasta [Pegfilgrastim]
Neumega [Oprelvekin]
Neupogen [Filgrastim]
Oncaspar [Pegaspargase]
Ontak [Denileukin diftitox]
Proleukin [Aldesleukin]
Rituxan [Rituximab]
Zevalin [Ibritumomab tiuxetan]
|
Division of Medical Imaging and Hematology Products |
Diagnostic imaging Hematology
Venous vascular disorders
|
Abbokinase [Urokinase]
Aranesp [Darbepoetin alfa]
CEA-Scan TM [Arcitumomab]
Epogen [Epoetin alfa]
NeutroSpec [Technetium fanolesomab]
Procrit [Epoetin alfa]
ProstaScint [Capromab Pendetide]
Verluma [Nofetumomab]
|
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Date created: October 1, 2003, updated: May 1, 2008 |
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