FDA Biopharmaceutical Product Approvals and Trends:
Significantly More Approvals Were Granted in 2009*

    

Table 1.  FDA Full Biopharmaceutical Approvals in 2009
Product
Company
Date
Indication
vWF/Factor VIII Complex (Wilate) Octapharma USA, Inc.12/4/2009von Willebrand's disease**
Kallikrein inhibitor, rDNA (Kalbitor) Dyax Inc. 12/1/2009hereditary angioedema (HAE)**
Influenza vaccine/Novartis Italy (Agriflu) Novartis 11/27/2009influenza prophylaxis
CD20 Mab, human, rDNA (Arzerra) GlaxoSmithKline (and Genmab)10/26/2009chronic lymphocytic leukaemia**
Antitrypsin, alpha-1, conc./Talecris (Prolastin-C) Talecris Biotherapeutics 10/19.2009 alpha1-antitrypsin (AAT) deficiency**
HPV vaccine, rDNA/GSK (Cervarix) GlaxoSmithKline 10/16/2009 cervical cancer prophylaxis
C1-esterase inhibitor/CSL (Berinert P) CSL Behring LLC 10/09/2009 hereditary angioedema (HAE)**
IL-12/23 p40 Mab, rDNA (Stelara) Ortho Biotech Inc.  (Johnson & Johnson) 9/25/2009 plaque psoriasis**
Immune Globulin (IGIV)/Bio Products (Gammaplex) Bio Products Lab. 9/17/2009 primary immunodeficiency**
Haemophilus b Vaccine/GSK (Hiberex) GlaxoSmithKline 8/19/2009 Haemophilus influenzae prophylaxis
Interferon betaser, rDNA/Novartis (Extavia)* Novartis (and Bayer Schering) 8/15/2009 multiple sclerosis**
Interleukin-1 Mab, rDNA (Ilaris) Novartis 6/17/2009 Cryopyrin Associated Periodic Syndrome (CAPS)**
Pancreatic Enzyme/Solvay (Creon)* Solvay 5/1/2009 pancreatic enzyme insufficiency
Botulinum Toxin A/Ipsen (Dysport; Reloxin) Ipsen 4/29/2009 cervical dystonia**; gabellar (frown) lines
TNF Mab, rDNA, human/J&J (Simponi) Centocor Ortho Biotech Inc.  (Johnson & Johnson) 4/24/2009 immune dysfunction-related arthritis
Japanese Encephalitis Vaccine/Intercell (Ixiaro) Intercell Biomedical (and Novartis) 3/30/2009 Japanese encephalitis virus prophylaxis
Antithrombin III, rDNA (ATryn) GTC Biotherapeutics, Inc.  (Genzyme) 2/6/2009 antithrombin deficiency**
Fibrinogen/CSL (RiaSTAT) CSL Behring 1/16/2009 congenital fibrinogen deficiency**