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U.S. Department of Health and Human Services

Drugs

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Therapeutic Biologic Applications (BLA)

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/DIVISIONINDICATIONPRODUCT
Division of Cardiovascular and Renal ProductsRenal Disorders
Cardiology Disorders
Arterial Vascular Disorders
Activase [Alteplase]
Cathflo Activase [Alteplase]
ReoPro [Abciximab]
Retavase [Reteplase]
Streptase [Streptokinase]
TNKase [Tenecteplase]
Division of Neurology ProductsNeurology 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

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OFFICE OF DRUG EVALUATION II

RESPONSIBLE OFFICE/DIVISIONINDICATIONPRODUCT
Division of Metabolism and Endocrinology Products

Dyslipidemias

Obesity

Diabetes

Growth disorders

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Division of Pulmonary, Allergy and Rheumatology Products

Allergy
Pulmonary

Rheumatology

Pulmozyme [Dornase alfa]
Xolair [Omalizumab]
Enbrel [Etanercept]
Humira TM [Adalimumab]
Kineret [Anakinra]
Orencia [Abatacept]
Remicade [Infliximab]
Benlysta [Belimumab]
Ilaris [Canakinumab]
Xiaflex [Clostridial collagenase]
Kalbitor [Ecallantide]
Simponi [Golimumab]
Krystexxa [Pegloticase]
Arcalyst [Rilonacept]
Actemra [Tocilizumab]
 

Division of Anesthesia, Analgesia and Addiction Products

Pain treatment (including peripheral neuropathies that are intrinsically painful)

Anesthesia

Addiction

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OFFICE OF DRUG EVALUATION III

RESPONSIBLE OFFICE/DIVISIONINDICATIONPRODUCT
Division of Reproductive and Urologic ProductsUrologic
Reproductive

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Division of Gastroenterology ProductsGastrointestinal (includes non-viral hepatic disorders) Genetic metabolic (inborn) disorders
Large volume parenterals

Aldurazyme [Laronidase]
Fabrazyme [Agalsidase beta]
Naglazyme [Galsulfase]

Division of Dermatology and Dental ProductsDental
Dermatology
Alferon N Injection [Interferon alfa-n3]
Amevive [Alefacept]
Raptiva [Efalizumab]
Regranex [Becaplermin]
Santyl [Collagenase]

OFFICE OF ANTIMICROBIAL PRODUCTS

RESPONSIBLE OFFICE/DIVISIONINDICATIONPRODUCT
Division of Anti-Infective and Ophthalmology ProductsBacterial infectious disease Sepsis
Ophthalmology
Xigris [Drotrecogin alfa (activated)]
Division of Special Pathogen and Transplant ProductsSolid 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 ProductsViral infections, including viral hepatitisCopasys 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/DIVISIONINDICATIONPRODUCT
Division of Drug Oncology ProductsAll small molecule cancer treatments
Consolidated from many different divisions
Cancer Prevention

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Division of Biologic Oncology ProductsBiologic 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 ProductsDiagnostic 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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