Product
(Bold text indicates recombinant and monoclonal antibody products) |
Company |
Application |
FDA Approval Date |
Abelcet®
(liposomal formulation of amphotericin B) | Enzon | Treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B | Nov 1995
|
Abreva™
(docosanol) | AVANIR Pharmaceuticals and GlaxoSmithKline, Inc. | Topical treatment of recurrent cold sores (herpes simplex infection) | Jul 2000
|
Actimmune®
(interferon gamma-1b) | InterMune Pharmaceuticals, Inc. | Treatment of chronic granulomatous disease; Treatment of severe, malignant osteopetrosis | Dec 1990
Feb 2000
|
Activase®/Cathflo® Activase®
(alteplase; tissue plasminogen activator) | Genentech, Inc. | Treatment of acute myocardial infarction; Acute massive pulmonary embolism; Acute ischemic stroke within first three hours of symptom onset; Dissolution of clots in central venous access devices | Nov 1987
Jun 1990
Jun 1996
Sep 2001
|
AcuTect™
(technetium Tc-99 apcitide) | Berlex Laboratories | Imaging agent for deep-vein thrombosis | Sep 1998
|
Adagen®
(adenosine deaminase) | Enzon, Inc. | Treatment of severe combined immunodeficiency disease (SCID) | Mar 1990
|
Advate
(Recombinant antihemophilic factor produced without any added human or animal plasma proteins and albumin) | Baxter Healthcare Corp. | Hemophilia A | Jul 2003
|
Agenerase®
(amprenavir) | Vertex Pharmaceuticals and GlaxoSmithKline | HIV | Apr 1999
|
Albutein®
(human albumin) | Alpha Therapeutic Corp. | Treatment of hypovolemic shock; an adjunct in hemodialysis; used in cardiopulmonary bypass procedures | Jan 1986
|
Aldurazyme®
(Laronidase; recombinant enzyme replacement) | BioMarin Pharmaceuticals Inc. and Genzyme | Mucopolysaccharidosis-1 | Apr 2003
|
Alferon N®
(interferon alfa-N3, human leukocyte derived) | Interferon Sciences, Inc | Treatment of genital warts | Oct 1989
|
Aloxi
(Palonosetron HCI injection; 5-HT3 receptor antagonist) | MGI Pharma Inc. and Helsinn Healthcare SA | Prevention of acute nausea and vomiting in chemotherapy patients | Jul 2003
|
Alphanate®
(human antihemophilic factor) | Alpha Therapeutic Corp. | Treatment of hemophilia A or acquired factor VIII deficiency | Feb 1997
|
AlphaNine® SD
(virus-filtered human coagulation factor IX) | Alpha Therapeutic Corp. | Prevention and control of bleeding in patients with factor IX deficiency due to hemophilia B | Jul 1996
|
AmBisome®
(liposomal amphotericin B) | Gilead Sciences, Inc., and Fujisawa Healthcare | Treatment of fungal infections in patients with depressed immune function and with fever of unknown origin; Treatment of cryptococcal meningitis in HIV-infected patients | Aug 1997
Jun 2000
|
Amevive®
(Alefacept; recombinant, dimeric fusion protein; targets CD45RO+ T-cells) | Biogen Idec | Moderate to severe chronic plaque psoriasis | Jan 2003
|
AMPHOTEC®
(lipid-based colloidal dispersion of amphotericin B) | InterMune Pharmaceuticals, Inc. | Second-line treatment of invasive aspergillosis infections | Nov 1996
|
AndroGel™
(testosterone) | Unimed Pharmaceuticals, Inc. (subsidiary of Solvay Pharmaceuticals) | Testosterone-replacement therapy in males with testosterone deficiency | Feb 2000
|
Angiomax®
(bivalirudin) | The Medicines Company | Anticoagulant in conjunction with aspirin in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty | Dec 2000
|
Apligraf®
(living human skin substitute, from collagen, fibroblasts and keratinocytes) | Organogenesis, Inc., and Novartis Pharmaceuticals Corp. | Treatment of venous leg ulcers; Treatment of diabetic foot ulcers | May 1998
Jun 2000
|
Aranesp™
(darbepoetin alfa) | Amgen | Anemia associated with chronic renal failure; Chemotherapy-induced anemia in patients with non-myeloid malignancies | Sep 2001
Jul 2002
|
| Argatroban | Texas Biotechnology Corp. and GlaxoSmithKline | Anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia; Anticoagulant for use in patients with or at risk of heparin-induced thrombocytopenia undergoing percutaneous coronary interventions | Jun 2000
Apr 2002
|
AVAGE™
(tazarotene; also marketed as Tazorac®) | Allergan Inc. | Topical treatment of facial fine wrinkling, mottled hypo- and hyperpigmentation, and benign facial lentigines | Oct 2002
|
Avastin™
(bevacizumab) | Genentech | First-line treatment, in combination with 5-FU, in metastatic colorectal cancer. | Feb 2004
|
AVINZA™
(extended-release morphine sulfate) | Ligand Pharmaceuticals and Elan Corp., plc | Once-daily treatment of moderate to severe pain in patients who require continuous opioid therapy for an extended period of time | Mar 2002
|
Avonex®
(Interferon beta-1a; recombinant) | Biogen Idec | Treatment of relapsing-remitting forms of multiple sclerosis; Treatment after initial MS attack if a brain MRI scan shows abnormalities characteristic of the disease | May 1996
Feb 2003
|
BeneFix™
(coagulation factor IX) | Wyeth | Treatment of hemophilia B | Feb 1997
|
Betaseron®
(Interferon beta-1b) | Berlex Laboratories and Chiron Corporation | Treatment of relapsing-remitting multiple sclerosis; New labeling includes data from studies in patients with secondary progressive multiple sclerosis; and the indications section reflects Betaseron is indicated for treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations | Aug 1993
Mar 2003
|
BEXXAR®
(Tositumomab and I-131 tositumomab; monoclonal antibody targeting the CD20 antigen and radiolabeled version of the antibody) | Corixa Corp. and GlaxoSmithKline | CD20-positive, follicular non-Hodgkin's lymphoma whose cancer is refractory to Rituxan® and has relapsed following chemotherapy. | Jun 2003
|
Bioclate™
(antihemophilic factor) | Aventis Behring | Treatment of hemophilia A for the prevention and control of hemorrhagic episodes; perioperative management of patients with hemophilia A | Dec 1993
|
BioTropin™
(human growth hormone) | Biotech General | Treatment of human growth hormone deficiency in children | May 1995
|
BOTOX® COSMETIC
(botulinum toxin type A) | Allergan Inc. | Cervical dystonia in adults; Treatment of strabismus and blepharospasm associated with dystonia; Temporary improvement in appearance of moderate to severe glabellar lines (frown lines) in adults 65 or younger | Dec 1989
Dec 2000
Apr 2002
|
Campath®
(alemtuzumab) | Ilex Oncology, Inc., Millennium Pharmaceuticals, Inc., and Berlex Laboratories, Inc. | B-cell chronic lymphocytic leukemia in patients who have been treated with alkylating agents and who have failed fludarabine therapy | May 2001
|
Carticel™
(autologous cultured chondrocytes) | Genzyme | Reconstruction of damaged knee cartilage | Aug 1997
|
CEA-Scan®
(acritumomab; technetium-99 labeled) | Immunomedics, Inc. | Imaging agent for metastatic colorectal cancer | Jun 1996
|
Ceredase®
(alglucerase; modified form of beta-glucocerebrosidase) | Genzyme | Treatment of type 1 Gaucher's disease | Apr 1991
|
Cerezyme®
(imiglucerase; recombinant form of beta-glucocerebrosidase) | Genzyme | Treatment of type 1 Gaucher's disease | May 1994
|
Cialis®
(Tadalafil; oral PDE5 inhibitor) | Lilly ICOS LLC (joint venture of Eli Lilly and Co. and ICOS Corp. | Erectile dysfunction | Nov 2003
|
Comvax™
(Haemophilus B conjugate [meningococcal conjugate] and hepatitis B [recombinant] vaccine) | Merck & Co., Inc. | Vaccination against Haemophilus influenzae type B and against all known subtypes of hepatitis B in infants born to HbsAg-negative mothers | Oct 1996
|
CosmoDerm™/CosmoPlast™
(Dermal fillers containing human-based collagen) | Advanced Tissue Sciences Inc. and Inamed Corp. | Wrinkles | Mar 2003
|
CroFab™
(crotalidae polyvalent immune Fab, ovine) | Protherics, plc, and Savage Laboratories (unit of Altana, Inc.) | Rattlesnake antivenom | Oct 2000
|
Cubicin™
(Daptomycin for injection) | Cubist Pharmaceuticals Inc. and Chiron Corp. | Bacterial infections | Sep 2003
|
CytoGam®
(CMV immune globulin IV) | MedImmune, Inc. | Prevention of CMV disease associated with kidney, lung, liver, pancreas and heart transplants; Prevention of cytomegalovirus (CMV) in kidney transplant patients | Apr 1990
Dec 1998
|
DaunoXome®
(liposomal form of the chemotherapeutic agent daunorubicin) | Gilead Sciences | First-line treatment for HIV-related Kaposi's sarcoma | Apr 1996
|
Depocyt™
(sustained release formulation of cytarabine) | SkyePharma and Enzon | Treatment of lymphomatous meningitis | Apr 1999
|
Dermagraft®
(human-based, tissue-engineered living dermal substitute) | Advanced Tissue Sciences Inc. and Smith & Nephew plc | Diabetic foot ulcers | Sep 2001
|
DigiFab™
(digoxin immune fab [ovine]) | Protherics plc | Digoxin toxicity | Sep 2001
|
Doxil®
(liposomal formulation of doxorubicin hydrochloride) | Alza (subsidiary of Johnson & Johnson) | Second-line therapy for Kaposi's sarcoma in AIDS patients; Metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimens | Nov 1995
Jun 1999
|
Elestat™
(Epinastine HCI ophthalmic solution 0.05%) | Inspire Pharmaceuticals Inc., Allergan Inc. (Inspire signed a co-promotion agreement following approval of the Allergan drug) and Boehringer Ingelheim | Prevention of itching associated with allergic conjunctivitis | Oct 2003
|
Eligard™
(slow-release formulation of leuprolide acetate) | Atrix Laboratories and Sanofi-Synthelabo | Advanced prostate cancer; Additional formulation cleared | Jul 2002
Jul 2002
|
Elitek®
(rasburicase) | Sanofi-Synthelabo | Management of plasma uric acid levels in pediatric chemotherapy patients | Jul 2002
|
Emtriva™
(Emtricitabine; once-daily nucleoside reverse transcriptase inhibitor [capsule]) | Gilead Sciences, Inc. | Treatment of HIV infection in adults as part of combination | Jul 2003
|
ENBREL®
(Etanercept; recombinant product; dimeric fusion protein consisting of tumor necrosis factor receptor linked to the Fc portion of human IgG1) | Amgen and Wyeth | Treatment of moderate to severely active rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying antirheumatic drugs; Treatment of polyarticular course juvenile rheumatoid arthritis; Treatment as a first-line therapy for moderate to severe active rheumatoid arthritis; Reduction of signs and symptoms of active arthritis in patients with psoriatic arthritis; Ankylosing spondylitis; Improvement of physical function in patients with moderately to severely active rheumatoid arthritis; Expanded psoriatic arthritis label claiming blockage of progression of structural damage | Nov 1998
May 1999
Jun 2000
Jan 2002
Jul 2003
Jul 2003
Aug 2003
|
Engerix-B®
(hepatitis B vaccine) | GlaxoSmithKline | Hepatitis B vaccine; Adults with chronic hepatitis C infection | Sep 1989
Aug 1998
|
Epogen®
(epoietin alfa) | Amgen | Treatment of anemia associated with chronic renal failure and anemia in Retrovir-treated HIV-infected patients; Pediatric use | Jun 1989
Jul 1999
|
Erbitux™
(cetuximab) | ImClone Systems Inc. | Patients with metastatic colorectal cancer who are refractory to or intolerant of irinotecan | Feb 2004
|
ESTRASORB™
(Estradiol topical emulsion) | Novavax, Inc. and King Pharmaceuticals, Inc. | Short-term use to reduce moderate to severe vasomotor symptoms ("hot flashes") in menopausal women | Oct 2003
|
Fabrazyme®
(Algasidase beta; recombinant enzyme replacement) | Genzyme | Fabry's disease | Apr 2003
|
FACTIVE®
(Gemifloxacin mesylate) | GeneSoft Pharmaceuticals, Inc. | Mild to moderate community-acquired pneumonia and acute bacterial exacerbation of chronic bronchitis; Community-acquired pneumonia due to multidrug-resistant Streptococcus pneumoniae | Apr 2003
Jul 2003
|
Fertinex™
(urofollitropin) | Serono S.A. | Treatment of female infertility to stimulate ovulation in women with ovulatory disorders and in women undergoing assisted reproductive technologies | Aug 1996
|
FluMist™
(nasally delivered influenza vaccine) | MedImmune, Inc. and Wyeth | Prevention of flu | Jun 2003
|
Focalin™
(dexmethylphenidate hydrochloride) | Celgene Corp. and Novartis Pharmaceuticals Corp. | Attention deficit hyperactivity disorder | Nov 2001
|
Follistim™
(follitropin beta) | Organon (unit of Akzo Nobel) | Recombinant follicle-stimulating hormone for treatment of infertility; Induction of spermatogenesis in men with primary and secondary hypo-gonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure | Sep 1997
Feb 2002
|
FortaFlex™
(bioengineered collagen matrix) | Organogenesis, Inc., and Biomet, Inc. | Rotator cuff repair | Apr 2002
|
FORTEO®
(teriparatide) | Eli Lilly and Company | Treatment of osteoporosis in postmenopausal women at high risk of fracture, and to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk of fracture | Nov 2002
|
Frova™
(frovatriptan succinate) | Vernalis Group, plc, and Elan Corp., plc | Migraine | Nov 2001
|
FUZEON™
(Enfuvirtide; fusion inhibitor [subcutaneous injection]) | Trimeris, Inc. and Roche | Component of combination therapy for HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy | Mar 2003
|
Ganite™
(Gallium nitrate injection) | Genta, Inc. | Cancer-related hypercalcemia that is resistant to hydration | Sep 2003
|
GenoTropin®
(human somatropin) | Pharmacia | Treatment of growth hormone deficiency in children; Growth hormone deficiency in adults; Long-term treatment of growth failure in children born small for gestational age who fail to catch up by age 2 | Aug 1995
Nov 1997
Jul 2001
|
| Geref® | Serono S.A. | Treatment of growth hormone deficiency in children with growth failure | Oct 1997
|
Gleevec™
(imatinib mesylate) | Novartis Pharmaceuticals Corp. | Chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy; Treatment of Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal tumors; First-line treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia | May 2001
Feb 2002
Dec 2002
|
Gliadel® wafer
(Polifeprosan 20 with carmustine implant) | Guilford Pharmaceuticals, Inc. | Newly diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation | Feb 2003
|
GlucaGen®
(glucagon) | Novo Nordisk | Treatment of severe hypoglycemic reactions in insulin-treated diabetics, and for diagnostic use | Jun 1998
|
Gonal-F®
(follitropin alfa) | Serono S.A. | Treatment of infertility in women not due to primary ovarian failure; Treatment of infertility in men and women | Sep 1998
Jun 2000
|
Helixate®
(antihemophilic factor) | Aventis Behring | Factor VIII for treatment of hemophilia A; Second-generation factor VIII formulated with sucrose for treatment of hemophilia A | Feb 1994
Jun 2000
|
Hepsera™
(adefovir dipivoxil) | Gilead Sciences, Inc. | Chronic hepatitis B | Sep 2002
|
Herceptin®
(trastuzumab) | Genentech, Inc. | Treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein | Sep 1998
|
Hextend®
(hetastarch) | BioTime, Inc. | Plasma volume expander for treatment of hypovolemia during surgery | Mar 1999
|
Humalog®
(insulin) | Eli Lilly and Company | Treatment of diabetes | Jun 1996
|
Humate-P®
(antihemophilic factor/von Willebrand factor complex–human) | Aventis Behring | Treatment and prevention of bleeding episodes in hemophilia A adult patients; spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease in adult and pediatric patients, and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate | Apr 1999
|
Humatrope®
(Somatotropin) | Eli Lilly and Company | Treatment of growth hormone deficiency in children; Somatotropin deficiency syndrome in adults; Long-term treatment of children of short stature (unknown cause) | Aug 1996
Mar 1997
Jul 2003
|
HUMIRA™
(adalimumab) | Cambridge Antibody Technologies and Abbott Laboratories | Patients with moderately to severely active rheumatoid arthritis who have had insufficient response to one or more traditional disease modifying antirheumatic drugs | Dec 2002
|
Humulin®
(human insulin) | Eli Lilly And Company | Treatment of diabetes | Oct 1982
|
Imagent®
(perflexane lipid microspheres) | Alliance Pharmaceutical Corp., Cardinal Health, Inc. and InChord Communications, Inc. | Imaging agent for use in echocardiography | Jun 2002
|
Infergen®
(interferon alfacon-1) | InterMune Pharmaceuticals, Inc., and Amgen | Treatment of hepatitis C (HCV) in patients 18 years or older with compensated liver disease who have anti-HCV serum antibodies and/or the presence of HCV RNA; Subsequent treatment of HCV-infected patients who have tolerated an initial course of interferon therapy | Oct 1997
Dec 1999
|
INFUSE™ Bone Graft/LT-CAGE™
(device utilizing recombinant human bone morphogenetic protein [rhBMP-2-]) | Wyeth and Medtronic Sofamor Danek | For use in spinal fusion surgery to treat certain types of spinal degenerative disease | Jul 2002
|
INTEGRA® Dermal Regeneration Template
(bilayer membrane system for skin replacement) | Integra LifeSciences Holding Corp. and Ethicon, Inc. (a unit of Johnson & Johnson) | Treatment of full-thickness and deep partial-thickness burns; Repair of scar contractures | Mar 1996
Apr 2002
|
Integrilin™
(eptifibatide for injection) | Millennium Pharmaceuticals and Schering-Plough Corp. | Acute coronary syndrome, including both patients managed medically and those undergoing percutaneous coronary intervention; Revised prescribing information with new dosing regimen for patients undergoing intracoronary stenting | May 1998
Jun 2001
|
Intron A®
(alpha-interferon) | Schering-Plough Corp. | Treatment of hairy cell leukemia; Genital warts; AIDS-related Kaposi's sarcoma; Non-A, non-B hepatitis; Hepatitis B; Chronic malignant melanoma; Extended therapy for chronic viral hepatitis C; Treatment for follicular lymphoma in conjunction with chemotherapy; Treatment of hepatitis B in pediatric patients | Jun 1986
Jun 1988
Nov 1988
Feb 1991
Jul 1992
Dec 1995
Mar 1997
Nov 1997
Aug 1998
|
Kineret™
(anakinra) | Amgen | Moderately to severely active rheumatoid arthritis in adult patients who have failed disease-modifying antirheumatic drugs | Nov 2001
|
Kogenate®FS
(antihemophilic factor) | Bayer Corp. | Factor VIII for treatment of hemophilia A; Second-generation factor VIII formulated with sucrose for treatment of hemophilia A | Sep 1989
Jun 2000
|
Lantus®
(insulin glargine) | Aventis | Biosynthetic basal insulin for adult and pediatric patients with type 2 diabetes | Apr 2000
|
Leukine®/Leukine® Liquid
(granulocyte macrophage colony-stimulating factor) | Berlex Laboratories | Treatment of autologous bone marrow transplantation; Treatment of white blood cell toxicities following induction chemotherapy in older patients with acute myelogenous leukemia; For use following allogenic bone marrow transplantation from HLA-matched related donors; For use mobilizing peripheral blood progenitor cells and for use after PBPC transplantation; Treatment of autologous bone marrow transplantation; treatment of white blood cell toxicities following induction chemotherapy in older patients with acute myelogenous leukemia; for use following allogenic bone marrow transplantation from HLA-matched related donors; for use mobilizing peripheral blood progenitor cel(Leukine® Liquid) ready-to-use formulation in a multidose vial | Mar 1991
Sep 1995
Nov 1995
Dec 1995
Nov 1996
|
Leustatin™
(cladribine or 2-CDA) | Ortho Biotech, Inc. (subsidiary of Johnson & Johnson) | First-line treatment of hairy cell leukemia | Mar 1993
|
Lexiva™
(Fosamprenavir calcium; protease inhibitor [tablet]) | Vertex Pharmaceuticals and GlaxoSmithKline | Treatment of HIV infection in adults in combination with other antiretrovirals | Oct 2003
|
Luxiq™
(betamethasone) | Connetics Corp. | Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp | Feb 1999
|
LYMErix™
(OspA lipoprotein) | SmithKline Beecham Biologicals (subsidiary of GlaxoSmithKline) | Prevention of Lyme disease | Dec 1998
|
Metadate® CD
(bi-phasic release formulation of methylphenidate) | Celltech Pharmaceuticals, Inc. | Attention deficit hyperactivity disorder | Apr 2001
|
Mitozytrex
(MitoExtra™ proprietary version of mitomycin) | SuperGen, Inc. | Disseminated adenocarcinoma of the stomach or pancreas | Nov 2002
|
Mylotarg™
(gemtuzumab ozogamicin) | Celltech Pharmaceuticals and Wyeth | Human antibody linked to calicheamicin (chemotherapeutic) for treatment of CD33 positive acute myeloid leukemia in patients 60 and older in first relapse who are not considered candidates for cytotoxic chemotherapy | May 2000
|
Myobloc™
(botulinum toxin type B) | Elan Corp. | Treatment of cervical dystonia | Dec 2000
|
Nabi-HB™
(hepatitis B immune globulin-human) | Nabi Pharmaceuticals | Treatment of acute exposure to HbsAg, perinatal exposure of infants born to HbsAg-positive mothers, sexual exposure to HbsAg-positive persons and household exposure of infants to persons with acute hepatitis B | Mar 1999
|
NAMENDA™
(Memantine HCI; N-methyl-D-aspartate receptor antagonist [tablet]) | Neurobiological Technologies, Inc. and Forest Laboratories | Moderate to severe Alzheimer's | Oct 2003
|
Natrecor®
(nesiritide) | Scios, Inc. | Acutely decompensated congestive heart failure with shortness of breath at rest or with minimal activity | Aug 2001
|
Neulasta™
(pegfilgrastim) | Amgen | Reduction of incidence of infection as manifested by febrile neutropenia in non-myeloid cancer patients receiving certain chemotherapies | Jan 2002
|
Neumega®
(oprelvekin) | Wyeth | Prevention of severe chemotherapy-induced thrombocytopenia in cancer patients | Nov 1997
|
Neupogen®
(filgrastim) | Amgen | Treatment of chemotherapy-induced neutropenia; Bone marrow transplant accompanied by neutropenia; Severe chronic neutropenia; Autologous bone marrow transplant engraftment or failure; Mobilization of autologous PBPCs after chemotherapy | Feb 1991
Jun 1994
Dec 1994
Dec 1995
Apr 1998
|
Norditropin®
(somatropin) | Novo Nordisk | Treatment of growth hormone deficiency in children | May 1995
|
Novantrone®
(mitoxantrone) | Amgen | Treatment of acute nonlymphocytic leukemia; Hormone refractory prostate cancer; Secondary progressive multiple sclerosis | Dec 1987
Nov 1996
Feb 2000
|
Novolin L®
(insulin; zinc suspension;) | Novo Nordisk | Treatment of diabetes | Jun 1991
|
Novolin N®
(insulin; isophane suspension) | Novo Nordisk | Treatment of diabetes | Jul 1991
|
Novolin R®
(insulin, regular;) | Novo Nordisk | Treatment of diabetes | Jun 1991
|
Novolin®
(insulin;) | Novo Nordisk | Treatment of diabetes | Oct 1982
|
Novolin® 70/30
(70% insulin isophane suspension and 30% regular insulin;) | Novo Nordisk | Treatment of diabetes | Jun 1991
|
NovoLog®
(insulin aspart) | Novo Nordisk | Insulin analog for adults with diabetes mellitus; For pump therapy in diabetes | May 2000
Dec 2001
|
NovoSeven®
(coagulation factor VIIa) | Novo Nordisk | Treatment of bleeding episodes in hemophilia A or B patients with inhibitors to factor VIII or factor IX | Mar 1999
|
Nutropin Depot™
(sustained-release formulation of somatropin) | Alkermes, Inc., and Genentech, Inc. | Growth hormone deficiency | Dec 1999
|
Nutropin®/Nutropin AQ®
(somatropin) | Genentech, Inc. | Treatment of growth hormone deficiency in children; Treatment of growth hormone deficiency in adults; Growth failure associated with chronic renal insufficiency prior to kidney transplantation; Short stature associated with Turner Syndrome; To improve spine bone mineral density observed in childhood-onset adult growth hormone-deficient patients and to increase serum alkaline phosphatase | Nov 1993
Jan 1994
Jan 1996
Dec 1996
Dec 1999
|
OLUX™ Foam
(clobetasol proprionate) | Connetics Corp. | Short-term topical treatment of moderate to severe dermatoses of the scalp; Short-term topical treatment of mild to moderate plaque-type psoriasis of non-scalp regions excluding the face and intertriginous areas | May 2000
Dec 2002
|
Oncaspar®
(PEG-L-asparaginase) | Enzon, Inc., and Rhone-Poulenc Rorer | Treatment of acute lymphoblastic leukemia in patients who are hypersensitive to native forms of L-asparaginase | Feb 1994
|
Ontak®
(denileukin diftitox) | Ligand Pharmaceuticals, Inc. | Treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the interleukin-2 receptor | Feb 1999
|
OrCel™
(composite cultured skin; bi-layered cellular matrix) | Ortec International, Inc. | For patients with recessive dystrophic epidemolysis bullosa undergoing hand reconstruction surgery; Treatment of donor site wounds in burn victims | Feb 2001
Aug 2001
|
Orfadin®
(nitisinone) | Swedish Orphan International AB and Rare Disease Therapeutics, Inc. | Hereditary tyrosinemia type 1 | Jan 2002
|
Orthoclone OKT3®
(muromomab-CD3) | Ortho Biotech, Inc. (subsidiary of Johnson & Johnson) | Reversal of acute kidney transplant rejection | Jun 1986
|
Orthovisc®
(hyaluronan) | Anika Therapeutics, Inc. | Pain from osteoarthritis of the knee. | Feb 2004
|
Ovidrel®
(human chorionic gonadotropin) | Serono S.A. | Treatment of infertility in women | Sep 2000
|
Pacis®
(live attenuated Bacillus Calmette-Guerin) | Shire BioChem, Inc. (subsidiary of Shire Pharmaceuticals Group, plc) and UroCor, Inc. | Bladder cancer immunotherapy | Mar 2000
|
Panretin®
(alitretinoin) | Ligand Pharmaceuticals, Inc. | The topical treatment of cutaneous lesions of patients with AIDS-related Kaposi's sarcoma | Feb 1999
|
Pediarix™
(diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B [recombinant] and inactivated polio-virus vaccine combined) | GlaxoSmithKline | Prevention of diphtheria, tetanus, pertussis, hepatitis B and polio | Dec 2002
|
Pegasys®
(peginterferon alfa-2a) | Roche and Nektar Therapeutics, Inc. | Chronic hepatitis C patients with compensated liver disease who have not been previously treated with alpha interferon; Combination therapy with Ribavirin in patients with chronic hepatitis C who have compensated liver disease and have not been previously treated with alpha interferon | Oct 2002
Dec 2002
|
PEG-Intron™
(pegylated version of interferon alfa-2b) | Enzon, Inc., and Schering-Plough Corp. | Monotherapy for chronic hepatitis C; Combination therapy with Rebetol for treatment of hepatitis C in patients with compensated liver disease | Jan 2001
Aug 2001
|
PHOTOFRIN® PDT
(Porfimer sodium; photodynamic therapy) | Axcan Pharma, Inc. | Palliative treatment of totally and partially obstructing cancers of esophagus; Ablation of high-grade dysplasia in Barrett's esophagus patients who do not undergo esophagectomy | Nov 1995
Aug 2003
|
Plenaxis™
(Abarelix (injectable suspension); gonadotropin-releasing hormone antagonist) | Praecis Pharmaceuticals Inc. | Palliative treatment of men with advanced symptomatic prostate cancer under certain conditions | Nov 2003
|
Prandin™
(repaglinide) | Novo Nordisk | Antidiabetic agent for treatment of type 2 diabetes | Dec 1997
|
Prevnar®
(pneumococcal 7-valent conjugate vaccine [diphtheria CRM-197 protein]) | Wyeth | Vaccine for infants and toddlers, 12–15 months, to prevent invasive pneumococcal disease; Immunization of infants and toddlers against otitis media caused by vaccine serotypes | Feb 2000
Oct 2002
|
Procrit®
(epoietin alfa) | Ortho Biotech, Inc. | Treatment of anemia in AZT-treated HIV-infected patients; Anemia in cancer patients on chemotherapy; For use in anemic patients scheduled to undergo elective noncardiac, nonvascular surgery | Dec 1990
Apr 1993
Dec 1996
|
Proleukin, IL-2®
(aldesleukin) | Chiron Corp. | Treatment of kidney carcinoma; Treatment of metastatic melanoma | May 1992
Jan 1998
|
ProstaScint®
(indium In 111 capromab pendetide) | Cytogen Corp. | Imaging agent for newly diagnosed patients with biopsy-proven prostate cancer | Oct 1996
|
Protropin®
(somatrem) | Genentech, Inc. | Treatment of growth hormone deficiency in children | Oct 1985
|
PROVIGIL®
(modafinil Tablets) | Cephalon, Inc. | To improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy; Excessive sleepiness associated with obstructive sleep apnea and shift-work sleep disorder; Excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome | Dec 1998
Jan 2001
Jan 2004
|
Pulmozyme®
(dornase alfa) | Genentech, Inc. | Treatment of mild to moderate cystic fibrosis; Treatment of advanced cystic fibrosis; Pediatric use in infants 3 months to 2 years and children 2 to 4 years old | Dec 1993
Dec 1996
Mar 1998
|
Quadramet
(samarium SM-153 lexidronam) | Berlex Laboratories and Cytogen Corp. | Pain relief in patients with osteoblastic metastatic bone lesions that enhance on radionuclide bone scan | Mar 1997
|
RAPTIVA™
(Efalizumab; selective, reversible T-cell blocker [subcutaneous injection; self-administered]) | Xoma, Ltd. and Genentech, Inc. | Chronic moderate to severe plaque psoriasis in adults | Oct 2003
|
Rebetron™
(combination of ribavirin and alpha interferon) | Schering-Plough Corp. | Combination therapy for treatment of chronic hepatitis C in patients with compensated liver disease who have relapsed following alpha-interferon treatment; Treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with alpha interferon therapy | Jun 1998
Dec 1998
|
Rebif®
(interferon beta 1-a) | Serono S.A., and Pfizer, Inc. | Relapsing forms of multiple sclerosis | Mar 2002
|
Recombinate® rAHF/
(antihemophilic factor) | Baxter Healthcare Corp. | Blood-clotting factor VIII for the treatment of hemophilia A | Feb 1992
|
Recombivax-HB®/Recombivax HB Dialysis Formulation
(hepatitis B vaccine) | Merck & Company, Inc. | Vaccination against hepatitis B; hepatitis B vaccine for adolescents and high-risk infants; adults; dialysis; pediatrics | Jul 1986
Jan 1987
Jan 1989
Jun 1993
|
ReFacto®
(antihemophilic factor) | Wyeth | Control and prevention of hemophilia A and short-term prophylaxis to reduce bleeding episodes | Mar 2000
|
Refludan®
(lepirudin) | Berlex Laboratories | For anticoagulation in patients with heparin-induced thrombocytopenia and associated thromboembolic disease in order to prevent further thromboembolic complications | Mar 1998
|
Regranex® Gel
(gel becaplermin) | Ortho-McNeil and Chiron Corp. | Platelet-derived growth factor treatment of diabetic foot ulcers | Dec 1997
|
REMICADE®
(Infliximab; recombinantly produced, chimeric monoclonal antibody) | Centocor, Inc. (subsidiary of Johnson & Johnson) | Short-term management of moderately to severely active Crohn's disease including those patients with fistulae; Treatment of patients with rheumatoid arthritis who have had inadequate response to methotrexate alone; Improving physical function in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate; Reducing signs and symptoms, and inducing and maintaining clinical remission in patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; Reduction of draining enterocutaneous and rectovaginal fistulas and for maintaining fistula closure in patients with fistulizing Crohn's disease | Aug 1998
Nov 1999
Feb 2002
Jun 2002
Apr 2003
|
Remodulin™
(treprostinil sodium) | United Therapeutics Corp. | Treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise | May 2002
|
Renagel® Capsules
(sevelamer hydrochloride) | Genzyme | Reduction of serum phosphorus in patients with end-stage renal disease (ESRD); Reduction of serum phosphorus in hemodialysis patients with end-stage renal disease | Nov 1998
Jul 2000
|
ReoPro™
(abciximab) | Centocor, Inc. (subsidiary of Johnson & Johnson) and Eli Lilly and Company | Reduction of acute blood clot-related complications for high-risk angioplasty patients; Reduction of acute blood clot complications for all patients undergoing any coronary intervention; treatment of unstable angina not responding to conventional medical therapy when percutaneous coronary intervention is planned within 24 hours | Dec 1994
Dec 1997
|
RespiGam®
(immune globulin enriched in antibodies against syncytial virus [RSV]) | MedImmune, Inc. | Prevention of respiratory syncytial virus in infants under 2 with bronchopulmonary dysplasia or history of prematurity | Jan 1996
|
RESTASIS™
(cyclosporine ophthalmic emulsion) | Allergan, Inc. | Chronic dry eye disease in patients whose tear production is presumed to be suppressed due to ocular inflammation | Dec 2002
|
Retavase™
(reteplase) | Centocor, Inc. (subsidiary of Johnson & Johnson) | Management of acute myocardial infarction in adults | Oct 1996
|
Risperdal® Consta™
(Risperidone; long-acting injection formulation uses Medisorb® drug delivery technology that encapsulates active medication in slow-degrading, polymer-based microspheres) | Alkermes, Inc. and Johnson & Johnson | Schizophrenia | Oct 2003
|
Rituxan™
(rituximab) | IDEC Pharmaceuticals Corp. and Genentech, Inc. | Treatment of relapsed or refractory low-grade or follicular, CD20-positive B-cell non-Hodgkin's lymphoma | Nov 1997
|
Roferon-A®
(interferon alfa-2a) | Hoffmann-La Roche, Inc. | Treatment of hairy cell leukemia; AIDS-related Kaposi's sarcoma; Chronic phase Philadelphia chromosome positive chronic myelogenous leukemia; Hepatitis C | Jun 1986
Nov 1988
Oct 1995
Nov 1995
|
Saizen®
(human growth hormone) | Serono S.A. | Treatment of growth hormone deficiency in children | Oct 1996
|
Sarafem™
(fluoxetine hydrochloride) | Interneuron Pharmaceuticals, Inc., and Eli Lilly and Company | Treatment of premenstrual dysphoric disorder | Jul 2000
|
SecreFlo™
(synthetic porcine secretin) | Repligen Corp. | Pancreatic assessment; Aid in location and cannulation of pancreatic ducts in patients undergoing endoscopic retrograde cholangiopancreatography | Apr 2002
Nov 2002
|
Sensipar™
(cinacalcet) | Amgen, Inc. | Secondary hyperthyroidism in kidney disease patients on dialysis; elevated calcium levels in patients with parathyroid carcinoma | Mar 2004
|
Simulect®
(basiliximab) | Novartis Pharmaceutical Corp. | Prevention of acute rejection episodes in kidney transplant recipients; Prevention of rejection in combination with triple immunosuppressive therapy in renal transplant; use in pediatric renal transplant; and use of IV bolus injection | May 1998
Mar 2001
|
SOMAVERT®
(Pegvisomant; pegylated version of a recombinant human growth hormone analog structurally altered to act as a GH receptor antagonist) | Nektar Therapeutics and Pfizer, Inc. | Acromegaly | Mar 2003
|
Synagis™
(Palivizumab; recombinantly produced, humanized monoclonal antibody) | MedImmune, Inc. | Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease; FDA cleared addition of new safety and efficacy data supporting the drug's use in young children with hemodynamically significant congenital heart disease | Jun 1998
Sep 2003
|
Tamiflu™
(oseltamivir phosphate) | Gilead Sciences, Inc., and Hoffmann-La Roche, Inc. | Treatment of most common strains of influenza in adults; Prevention of influenza in adolescents and adults; Treatment of acute influenza in children 1 year and older | Oct 1999
Nov 2000
Dec 2000
|
Targretin Gel®
(bexarotene) | Ligand Pharmaceuticals, Inc. | Topical treatment of cutaneous lesions in patients with early-stage cutaneous T-cell lymphoma | Jun 2000
|
Targretin®
(bexarotene) | Ligand Pharmaceuticals, Inc. | Treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy | Dec 1999
|
Thymoglobulin
(antithymocyte globulin; rabbit) | SangStat Medical Corp. | Treatment of acute rejection of kidney transplant in conjunction with immunosuppression | Dec 1998
|
Thyrogen®
(thyrotropin alfa) | Genzyme | Adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with thyroid cancer | Dec 1998
|
TNKase™
(tenecteplase) | Genentech, Inc. | Treatment of acute myocardial infarction | Jun 2000
|
Tracleer™
(bosentan) | Actelion Ltd. | Pulmonary arterial hypertension with WHO Class III or IV symptoms | Nov 2001
|
TriHIBit™
(combination vaccine for flu, diphtheria, tetanus and acellular pertussis) | Aventis Pasteur | Childhood immunization between 15 and 18 months for acellular pertussis, diphtheria, tetanus and HIB disease | Sep 1996
|
Tripedia®
(diphtheria, tetanus toxoids and acellular pertussis vaccine absorbed) | Aventis Pasteur | Diphtheria, tetanus and acellular pertussis vaccination of infants 2, 4 and 6 months of age; First booster at 15-18 months; Fifth dose at 4-6 years of age after four doses | Nov 1992
Jul 1996
Aug 2000
|
Trisenox™
(arsenic trioxide) | Cell Therapeutics, Inc. | Treatment of acute promyelocytic leukemia | Sep 2000
|
Twinrix®
(hepatitis A inactivated and hepatitis B [recombinant] vaccine) | SmithKline Beecham Biologicals (unit of GlaxoSmithKline) | Immunization against hepatitis A and B viruses | May 2001
|
VELCADE™
(Bortezomib for injection; proteasome inhibitor) | Millennium Pharmaceuticals, Inc. | Relapsed and refractory multiple myeloma | May 2003
|
Velosulin® BR
(insulin; buffered formulation) | Novo Nordisk | Diabetes | Jul 1999
|
Venoglobulin-S®
(human immune globulin intravenous 5% and 10% solutions) | Alpha Therapeutic Corp. | Treatment of primary immunodeficiencies; Idiopathic thrombocytopenic purpurea; Kawasaki disease | Nov 1991
Jan 1995
|
Viracept®
(nelfinavir) | Agouron Pharmaceuticals, Inc. (subsidiary of Pfizer) | HIV | Mar 1997
|
Viread™
(tenofovir disoproxil fumarate) | Gilead Sciences | For use in combination with other antiretroviral agents for treatment of HIV-1 infection | Oct 2001
|
VISTIDE®
(cidofovir injection) | Gilead Sciences, Inc. | Treatment of cytomegalovirus retinitis in AIDS patients | Jun 1996
|
Visudyne™
(verteporfin for injection) | QLT, Inc., and CIBA Vision | Treatment of wet form of age-related macular degeneration; Predominantly classic subfoveal choroidal neovascularization due to pathologic myopia (severe nearsightedness) | Apr 2000
Aug 2001
|
Vitravene™
(fomivirsen) | Isis Pharmaceuticals, Inc., and CIBA Vision | Treatment of cytomegalovirus retinitis in patients with AIDS | Aug 1998
|
WelChol™
(colesevelam) | Genzyme | Reduction of elevated low-density lipoprotein (LDL) cholesterol alone or in combination with HMG-CoA reductase inhibitor (statin) in patients with hypercholesterolemia | May 2000
|
Wellferon®
(interferon alfa-n1, lymphoblastoid) | GlaxoSmithKline | Treatment of chronic hepatitis C in patients 18 years of age or older without decompensated liver disease | Mar 1999
|
WinRho SDF®
(Rho[D] immune globulin) | Nabi Biopharmaceuticals | Prevention of Rh isoimmunization in pregnant women and the treatment of thrombocytopenic purpurea | Mar 1995
|
Xigris™
(drotrecogin alfa) | Eli Lilly and Company | Severe, life-threatening sepsis | Nov 2001
|
Xolair®
(Omalizumab; recombinant DNA-derived humanized monoclonal antibody targeting immunoglobulin-E [subcutaneous]) | Genentech, Tanox, Inc. and Novartis Pharmaceuticals | Moderate to severe persistent asthma in adults and adolescents | Jun 2003
|
Xyrem®
(sodium oxybate) | Orphan Medical, Inc. | Cataplexy associated with narcolepsy | Jul 2002
|
Zavesca™
(Miglustat; substrate reduction therapy [capsule]) | Celltech Group, plc and Actelion, Ltd. | Mild to moderate Type I Gaucher's disease patients for whom enzyme replacement therapy is not an option | Aug 2003
|
Zenapax®
(daclizumab) | Hoffmann-La Roche, Inc., and Protein Design Labs | Humanized monoclonal antibody for prevention of kidney transplant rejection | Dec 1997
|
Zevalin™
(ibritumomab tiuxetan) | IDEC Pharmaceuticals Corp. | Relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma | Feb 2002
|
Zonegran™
(zonisamide) | Elan Corp. | Adjunctive therapy in treatment of partial seizures in adults with epilepsy | Mar 2000
|
Zorbtive™ (Serostim® )
(Somatotropin) | Serono S.A. | Treatment of cachexia (AIDS-wasting); Short bowel syndrome | Aug 1996
Dec 2003
|
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You could try to write an article responding to the critics of biotech or you could try to just list the positives and refuse to engaged in dialogue because you are afraid you might lose if forced to argue with the many scientists who have issues with the way biotech research is headed (allowing companies to copywrite genes, FDA rules that treat biotech food as food rather than giving it the same scrutiny as chemical additives, attempts to make it illegal for the EU to require labelling of GM foods, questions about pollens from GM foods altering the DNA of nearby crops.....) To just list things treated by biotech doesnt provide any form of argument. It would be similar to an Iranian governent official responding to questions about their nuclear industry by pointing to low carbon emissions (you have come up with a list of positives without responding to the negatives).
Here are some sites with arguments you can respond to:
http://www.ucsusa.org/food_and_environment/biotechnology/index.cfm
http://www.foodfirst.org/ge/
http://www.reclaimthecommons.net/article.php?list=type&type=6
http://www.greenpeace.org/international_en/campaigns/intro?campaign_id=3942
http://www.biotech-info.net/index.html
http://www.consumersunion.org/i/Food_Safety/
http://www.iatp.org/
And some articles dealing with the issues protesters are bringing up (none of which are responded to in your list):
http://www.organicconsumers.org/monsanto/canolawar.cfm
http://www.biomedcentral.com/news/20021120/03
http://www.psrast.org/pollflow.htm
http://www.rawfoodinfo.com/articles/art_bumpyroadforGE.html
http://abcnews.go.com/sections/us/DailyNews/ge_salmon010509.html
http://www.chennaionline.com/science/biotechcorner/21biotech.asp
http://www.oneworld.org/guides/biotech/Vandana.htm
http://www.economist.com/displaystory.cfm?story_id=2724420
knowledge and health should be free and open to public scrutiny of the ill-side effects, etc. Not patented by profit driven motives by CEOs trying to make a buck.
I still have yet to see a good argument on why we shouldn't resist the biotech/biomed/big-pharma industry. Anyone have a better argument?
http://sf.indymedia.org/news/2004/06/1696442_comment.php#1696766