Products being transferred to CDER include:

• monoclonal antibodies for in vivo use
• cytokines, growth factors, enzymes, immunomodulators; and thrombolytics
• proteins intended for therapeutic use that are extracted from microorganisms or animals, including recombinant versions of these products (except clotting factors)
• non-vaccine therapeutic immunotherapeutics

Products remaining within CBER include:

• vaccines, including therapeutic vaccines
• blood, blood components and related products
• toxoids and toxins intended for immunization
• antitoxins, antivenins, and venoms
• gene therapies (viral and other vector-based)
• products composed of human or animal cells or from physical parts of those cells
• allergen patch tests and allergenics (not included in BIOPHARMA)
• some in vitro diagnostics, e.g., HIV test kits (not included in BIOPHARMA)

Specific currently-approved biologics (with therapeutic indications) being transferred to CDER include [FDA proper/official name followed by trade name]:

• Abciximab (ReoPro)
• Adalimumab (Humira)
• Agalsidase beta (Fabrazyme)
• Aldesleukin (Proleukin)
• Alefacept (Amevive)
• Alemtuzumab (Campath)
• Alteplase (Activase)
• Anakinra (Kineret)
• Anistreplase (Eminase)
• Arcitumomab (CEA-Scan)
• Asparaginase (Elspar)
• Basiliximab (Simulect)
• Becaplermin (Regranex)
• Becaplermin Concentrate
• Botulinum Toxin Type A (BOTOX; BOTOX COSMETIC)
• Botulinum Toxin Type B (MYOBLOC)
• Capromab Pendetide (ProstaScint)
• Collagenase (Santyl)
• Daclizumab (Zenapax)
• Darbepoetin alfa (Aranesp)
• Denileukin diftitox (Ontak)
• Dornase alfa (Pulmozyme)
• Drotrecogin alfa (Activated) (Xigris)
• Epoetin alfa (Epogen)
• Epoetin alfa (Eprex)
• Etanercept (Enbrel)
• Filgrastim (Neupogen)
• Ibritumomab tiuxetan (Zevalin)
• Infliximab (Remicade)
• Interferon alfa-2a (Roferon A)
• Interferon alfa-2b (Intron A)
• Interferon alfacon-1 (Infergen)
• Interferon alfa-n3 (Human Leukocyte Derived) (Alferon N)
• Interferon beta-1a (Avonex)
• Interferon beta-1a (Rebif)
• Interferon beta-1b (Betaseron)
• Interferon gamma-1b (Actimmune)
• Laronidase (Aldurazyme)
• Muromonab-CD3 (Orthoclone OKT3)
• Nofetumomab (Verluma)
• Oprelvekin (Neumega)
• Palivizumab (Synagis)
• Pegaspargase (Oncaspar)
• Pegfilgrastim (Neulasta)
• Peginterferon alfa-2a (Pegasys)
• Peginterferon alfa-2b (PEG-Intron)
• Rasburicase (Elitek)
• Reteplase (Retavase)
• Rituximab (Rituxan)
• Rituximab Formulated Bulk (For Further Manufacturing Use)
• Sargramostim (Leukine)
• Satumomab Concentrate (For Further Manufacturing Use))
• Satumomab Pendetide (OncoScint CR/OV)
• Streptokinase (Streptase)
• Tenecteplase (TNKase)
• Trastuzumab (Herceptin)
• Urokinase (Abbokinase)

For official information visit the CBER, FDA Web site

Treatment of product transfers in BIOPHARMA - Product monographs report whether the product was originally approved/regulated by CBER as a biologic, by CDER as a drug, etc. "Biologic," "Drug," etc., is indicated in the FDA Class field, including whether approval was a PLA (Product License Application) or, for more recent biologics approvals, a BLA (Biologics License Application). All or most biologics have had their approvals converted to (reapproved as) a BLA in recent years, and this also indicated in the FDA Class field where information, e.g., dates, are available. The transfer of certain biologics to CDER will generally not change their approval status, i.e., they will remain regulated as biologics (and biologics will continue to receive approvals as BLAs rather than NDAs). Transfer of products from CBER to CDER was formalized in early 2004 (and is fully covered in the 3rd edition). Products transferred from CBER to CDER can be readily retrieved from the BIOPHARMA Web database using the Approval Status field.