Approved recombinant drugs in the world
06 September 2005 | News
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) | ||
| BeneFixâ„¢ (coagulation factor IX) | Wyeth | Feb-97 |
| Betaseron® (Interferon beta-1b) | Berlex Laboratories and Chiron Corporation | Aug 1993, Mar 2003 |
| Bioclateâ„¢ (antihemophilic factor) | Aventis Behring | Dec-93 |
| BioTropinâ„¢ (human growth hormone) | Biotech General | May-95 |
| Cerezyme® (imiglucerase; recombinant | Genzyme | May-94 |
| form of beta-glucocerebrosidase) | ||
| Comvaxâ„¢ (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 | ||
| INFUSEâ„¢ Bone Graft/LT-CAGEâ„¢ | 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 Depotâ„¢ | 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-Intronâ„¢ | 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 |
| Rebetronâ„¢ (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 |
| Retavaseâ„¢ (reteplase) | Centocor, Inc. (subsidiary of | Oct-96 |
| Johnson & Johnson) | ||
| Roferon-A® (interferon alfa-2a) | Hoffmann-La Roche, Inc. | Jun 1986, Nov 1988, Oct 1995, |
| Nov-95 | ||
| 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 | ||
| antagonist) | ||
| TNKaseâ„¢ (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 |
| Xigrisâ„¢ (drotrecogin alfa) | Eli Lilly and Company | Nov-01 |
| Zorbtiveâ„¢ (Serostim® ) (Somatotropin) | Serono S.A. | Aug 1996, Dec 2003 |
Source: Bio.org
