• 6 September 2005
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Approved recombinant drugs in the world


Approved recombinant drugs in the world

 Product  Company  FDA Approval Date
Actimmune® (interferon gamma-1b) InterMune Pharmaceuticals, Inc. Dec 1990,Feb 2000
Activase®/Cathflo® Activase® Genentech, Inc.  Nov 1987, Jun 1990,Jun1996,
(alteplase; tissue plasminogen activator)   Sep-01
Advate(Recombinant antihemophilic factor Baxter Healthcare Corp. Jul-03
produced without any added human or    
animal plasma proteins and albumin)    
Aldurazyme® BioMarin Pharmaceuticals Apr-03
(Laronidase; recombinant enzyme replacement) Inc. and Genzyme  
Alferon N® Interferon Sciences, Inc Oct-89
(interferon alfa-N3, human leukocyte derived)    
Alphanate® Alpha Therapeutic Corp. Feb-97
(human antihemophilic factor)    
Amevive® Biogen Idec Jan-03
(Alefacept; recombinant, dimeric fusion    
protein; targets CD45RO+ T-cells)    
Avonex® Biogen Idec May 1996, Feb 2003
(Interferon beta-1a; recombinant)    
BeneFix™ (coagulation factor IX) Wyeth Feb-97
Betaseron® (Interferon beta-1b) Berlex Laboratories and Chiron Corporation Aug 1993, Mar 2003
Bioclate™ (antihemophilic factor) Aventis Behring Dec-93
BioTropin™ (human growth hormone) Biotech General May-95
Cerezyme® (imiglucerase; recombinant Genzyme May-94
form of beta-glucocerebrosidase)    
Comvax™ (Haemophilus B conjugate Merck & Co., Inc. Oct-96
[meningococcal conjugate]    
and hepatitis B [recombinant] vaccine)    
ENBREL® (Etanercept; recombinant Amgen and Wyeth Nov 1998, May 1999, Jun 2000,
product; dimeric fusion protein consisting of   Jan 2002, Jul 2003, Aug 2003,
tumor consisting of tumor necrosis factor   Apr 2004, Sep 2004
receptor linked to the Fc portion of human IgG1)    
Engerix-B® (hepatitis B vaccine) GlaxoSmithKline Sep 1989, Aug 1998
Epogen® (epoietin alfa) Amgen Jun 1989, Jul 1999
Fabrazyme® (Algasidase beta; Genzyme Apr-03
recombinant enzyme replacement)    
GenoTropin® (human somatropin) Pharmacia Aug 1995, Nov 1997, Jul 2001
Geref® Serono S.A. Oct-97
GlucaGen® (glucagon) Novo Nordisk Jun-98
Gonal-F® (follitropin alfa) Serono S.A. Sep 1998, Jun 2000
Helixate® (antihemophilic factor) Aventis Behring Feb 1994, Jun 2000
Humalog® (insulin) Eli Lilly and Company Jun-96
Humatrope® (Somatotropin) Eli Lilly and Company Aug 1996, Mar 1997, Jul 2003
Humulin® (human insulin) Eli Lilly And Company Oct-82
Infergen® (interferon alfacon-1) InterMune Pharmaceuticals, Oct 1997, Dec 1999
  Inc., and Amgen  
INFUSE™ Bone Graft/LT-CAGE™ Wyeth and Medtronic Sofamor Danek Jul 2002, Apr 2004
(device utilizing recombinant human bone    
 morphogenetic protein [rhBMP-2-])    
Intron A® (alpha-interferon) Schering-Plough Corp. Jun 1986, Jun 1988, Nov 1988,
    Feb 1991, Jul 1992, Dec 1995,
    Mar 1997, Nov 1997, Aug 1998
Leukine®/Leukine® Liquid (granulocyte Berlex Laboratories Mar 1991, Sep 1995, Nov 1995,
macrophage colony-stimulating factor)    Dec 1995, Nov 1996
Norditropin® (somatropin) Novo Nordisk May-95
Novolin L® (insulin; zinc suspension;) Novo Nordisk Jun-91
Novolin N® Novo Nordisk Jul-91
(insulin; isophane suspension)    
Novolin R® (insulin, regular;) Novo Nordisk Jun-91
Novolin® (insulin;) Novo Nordisk Oct-82
Novolin® 70/30 (70% insulin isophane Novo Nordisk Jun-91
suspension and 30% regular insulin;)    
NovoLog® (insulin aspart) Novo Nordisk May 2000, Dec 2001
NovoSeven® (coagulation factor VIIa) Novo Nordisk Mar-99
Nutropin Depot™ Alkermes, Inc., and Genentech, Inc. Dec-99
(sustained-release formulation of somatropin)    
Nutropin®/Nutropin AQ® (somatropin) Genentech, Inc. Nov 1993, Jan 1994, Jan 1996,
    Dec 1996, Dec 1999
Pegasys® (peginterferon alfa-2a) Roche and Nektar Therapeutics, Inc. Oct 2002, Dec 2002
PEG-Intron™ Enzon, Inc., and Schering-Plough Corp. Jan 2001, Aug 2001
(pegylated version of interferon alfa-2b)    
Procrit® (epoietin alfa) Ortho Biotech, Inc. Dec 1990, Apr 1993, Dec 1996
Proleukin, IL-2® (aldesleukin) Chiron Corp. May 1992, Jan 1998
Protropin® (somatrem) Genentech, Inc. Oct-85
Rebetron™ (combination of Schering-Plough Corp. Jun 1998, Dec 1998
ribavirin and alpha interferon)    
Rebif® (interferon beta 1-a) Serono S.A., and Pfizer, Inc. Mar-02
Recombinate® rAHF/ (antihemophilic factor) Baxter Healthcare Corp. Feb-92
Recombivax-HB®/ Recombivax HB Dialysis Merck & Company, Inc. Jul 1986, Jan 1987, Jan 1989,
Formulation (hepatitis B vaccine)   Jun-93
ReFacto® (antihemophilic factor) Wyeth Mar-00
Retavase™ (reteplase) Centocor, Inc. (subsidiary of Oct-96
  Johnson & Johnson)  
Roferon-A® (interferon alfa-2a) Hoffmann-La Roche, Inc. Jun 1986, Nov 1988, Oct 1995,
Saizen® (human growth hormone) Serono S.A. Oct 1996, Aug 2004
SOMAVERT® (Pegvisomant; pegylated version Nektar Therapeutics and Pfizer, Inc. Mar-03
of a recombinant human growth hormone analog    
structurally altered to act as a GH receptor    
TNKase™ (tenecteplase) Genentech, Inc. Jun-00
Twinrix® (hepatitis A inactivated SmithKline Beecham Biologicals May-01
and hepatitis B [recombinant] vaccine) (unit of GlaxoSmithKline)  
Wellferon® (interferon alfa-n1, lymphoblastoid) GlaxoSmithKline Mar-99
Xigris™ (drotrecogin alfa) Eli Lilly and Company Nov-01
Zorbtive™ (Serostim® ) (Somatotropin) Serono S.A. Aug 1996, Dec 2003

Source: Bio.org

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