| 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 |
