Therapeutic Biologic Applications (BLA)

• Approval Information (Labels and Reviews)
• Letters to Industry, Healthcare Providers, and Clinical Investigators
• Prescription Drug User Fee Act (PDUFA) Billable Products (PDF)  (updated March 2009)
• Recalls and Withdrawals
• Research Divisions and Investigators
• Safety Information
• Violative Advertising and Promotional Labeling Letters
• Frequently Asked Questions About Therapeutic Biological Products
• Important Addresses
  • Investigational New Drug Applications 
  • Required Postmarketing Adverse Experience Information
  • Advertising and Promotional Labeling
  • Reports of Biologic Product Deviations
  • Biologic License Applications (BLAs), BLA Supplements, Annual Reports on Postmarketing Studies, Postmarketing Study Final Reports, Postmarketing Study Correspondence, and Distribution Reports

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]