Biopharmaceutical Products in the U.S. and European Markets - FDA Approvals Web Site

Low FDA Approvals of New Biopharmaceuticals Continued in 2008

Table 1.  FDA Full Biopharmaceutical Approvals in 2008
Product
Company
Date
Indication
C1-esterase inhibitor (Cinryze)Sanquin & Lev10/10/2008 hereditary angioedema (C1 inhibitor deficiency)
Insulin aspart, rDNA, 50/50 mix (Novolog Mix 50/50)*Novo Nordisk8/26/2008diabetes
Thrombopoietin peptibody, rDNA (Nplate)Amgen8/22/2008chronic immune thrombocytopenic purpura
Pentacel (DTaP-Hib-Polio; Quadracel plus ActHib)*Sanofi Pasteur 6/20/20085-disese combination vaccine
Interferon alfa-2b, rDNA, PEG- & Ribavirin (PegPak)*Schering-Plough6/13/2008chronic hepatitis C
TNF Mab Fab', rDNA, PEG- (Cimzia)UCB & Bayer4/23/2008Crohn's disease
Rotavirus vaccine, live (Rotarix)GlaxoSmithKline4/04/2008rotavirus gastroenteritis prevention
DTaP-IPV (Kinrix)GlaxoSmithKline3/24/20084-disease combination vaccine
Fibrin Sealant (Artiss)Baxter3/19/2008attach/glue skin grafts onto burn patients
Interleukin-1 trap, rDNA (Arcalyst)Regeneron2/27/2008cryopyrin-associated periodic syndromes (CAPS)
Factor VIII, rDNA (Xyntha)Wyeth2/21/2008hemophilia A
Somatropin, rDNA (Accretropin)Cangene & Apotex1/24/2008pediatric growth failure; short stature
Thrombin, rDNA (Recothrom)Zymogenetics1/17/2008clotting agent; halt bleeding from surgery

*Approvals involving simple mixtures or combination use of previously approved products; not considered to be new biopharmaceutical products