2007:

1. EPO, rDNA, PEG- [Continuous Erythropoietin Receptor Activator; Mircera; CERA; epoetin alpha (recombinant), pegylated; methoxy polyethylene glycol-epoetin beta)] - granted on 11/14/07 to Hoffmann-La Roche Inc. for treatment of anemia associated with chronic renal failure in adults [Note, product may never be launched in U.S. due to infringement of patents held by Amgen (related lawsuit nearly but not yet finally resolved)].
2. Skin, Cultured/Epicel [Cultured Epidermal Autograft - Epicel; Cultured Autologous Keratinocytes Service; CEA] - HDE granted on 10/29/07 to Genzyme Corp. for the treatment of life-threatening wounds resulting from severe burns.
3. Influenza Vaccine/CSL [Influenza Virus Vaccine, Trivalent, Types A and B - AFLURIA; Fluvax; Enzira] - granted on 9/28/07 to CSL Ltd. for prophylaxis against influenza.
4. Smallpox vaccine/Vero - granted on 8/31/07 to Acambis plc for prophylaxis against smallpox (in the biodefense stockpile).
5. Thrombin/Omrix [Evithrom] - granted on 8/27/2007 to Omrix Biopharmaceuticals for control of bleeding (inaccessible/otherwise untreatable oozing of blood and minor bleeding from capillaries and small venules)
6. Fibrin Sealant/Thermogenesis [CryoSeal Fibrin Sealant System; CryoSeal FS System; cryoprecipitate plus thrombin, autologous]; granted on 7/26/2007 to Thermogenesis Corp. for control of bleeding during liver surgery
7. Immune Globulin (IGIV), liquid/CSL [Immune Globulin Intravenous (Human), 10% Liquid - Privigen]; granted on 7/26/2007 to CSL BioPlasma Inc. for treatment of primary immunodeficiency
8. Influenza Vaccine, H5N1/Sanofi [Influenza Virus Vaccine, H5N1; pandemic influenza vaccine; bird flu vaccine]; granted on 4/17/2007 to Sanofi Pasteur Inc. for active immunization of adults at increased risk of exposure to the H5N1 influenza virus [for use in case of a bird flu-related influenza epidemic/pandemic]
9. Somatropin, rDNA/BioPartners [Somatropin (rDNA origin) for Injection - Valtropin; human growth hormone, recombinant]; granted on 4/19/2008 to Parexel, a CRO proxy for LG Life Sciences, for treatment of growth deficiencies [Incredibly, despite this being a follow-on protein, generic drug approval, not a single news report has yet to came out about this, other than Signals magazine in fall 2007)! This author noticed Valtropin's approval in mid-March 2008, so it did not make it into the approvals review. Apparently, FDA neglected to announce this approval through normal channels at the time. Was this as "stealth" follow-on protein approval?].
10. Protein C, plasma-derived [Ceprotin]; granted on 3/27/2007 to Baxter Healthcare for treatment of severe congenital Protein C deficiency.
11. Complement C5 Mab, rDNA [Eculizumab - Soliris; complement C5 monoclonal antibody, recombinant] - granted on 3/16/07 to Alexion Pharmaceuticals, Inc. for ttreatment of paroxysmal nocturnal hemoglobinuria (PNH)
12. Poly-4-hydroxybutyrate, rDNA [TephaFLEX Absorbable Suture; poly-4-hydroxybutyrate; P4HB; poly(4HB); PHA4400] - granted on 2/12/2007 to Tepha, Inc. for use as surgical sutures

2006:

1. Albumin (Human) [one of many Albumin products] - granted on 10/17/06 to Octapharma Pharmazeutika Produktionsgesm.b.H for the restoration and maintenance of circulating blood volume
2. Influenza vaccine/ID Biomedical [Influenza Virus Vaccine, Trivalent - FluLaval; Fluviral] granted on 10/05/06 to GlaxoSmithKline (acquired ID Biomedical) for the active immunization of adults 18 years and older against influenza.
3. EGF receptor Mab, human, rDNA [Panitumumab - Vectibix; ABX-EGF; epidermal growth factor receptor monoclonal antibody, human, recombinant; E7.6.3; rHuMAb-EGFr; transgenic XenoMouse-derived human EGF receptor Mab]; granted on 9/27/2006 to Amgen Inc. "for the treatment of patients with epidermal growth factor receptor- (EGFr) expressing metastatic colorectal cancer after disease progression on, or following fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens"
4. Iduronate-2-sulfatase, rDNA [Idursulfase; Elaprase; L-iduronate 2-sulfate sulfatase precursor; recombinant; I2S; chondroitinsulfatase]; granted on 7/24/2006 to Shire Pharmaceuticals Group plc (through its acquisition of Transkaryotic Therapies, Inc.) for the treatment of Hunter syndrome (mucopolysaccharidosis II; MPS II).
5. VEGF Mab Fab, rDNA [Lucentis; vascular endothelial growth factor monoclonal antibody fragment, recombinant] granted on 6/30/2006 to Genentech, Inc. for treatment of age-related macular degeneration
6. HPV vaccine, rDNA/Merck [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine;- Gardasil; human papilloma virus (HPV) types 6, 11, 16 and 18 L1 virus-like proteins (VLPs), recombinant]; granted on 6/8/2006 to Merck & Co., Inc. for vaccination in females 9-26 years of age for prevention of diseases caused by human papillomavirus (HPV) types 6, 11, 16, and 18.
7. Somatropin, rDNA/Sandoz [Somatropin (rDNA origin) - Omnitrope; human growth hormone, recombinant] granted on 5/30/2006 to Sandoz, Inc., a subsidiary of Novartis AG, for treatment of growth hormone deficiency.
8. Varicella Virus Vaccine/adult [Zoster vaccine live (Oka/Merck); Zostavax; Varicella virus vaccine for adults]; granted on 5/25/2006 to Merck & Co., Inc. for prevention of herpes zoster (shingles) in persons 60 years of age or older.
9. Glucosidase, rDNA [Alglucosidase alfa - Myozyme; Pompase; alpha glucosidase; glucosidase alpha (rhGAA) [recombinant]]; granted on 4/28/2006 to Genzyme Corp. for treatment of Pompe disease.
10. Rotavirus Vaccine, rDNA/Merck [Rotavirus Vaccine, Quintavalent - RotaTeq; WC3 pentavalent vaccine]; granted on 2/3/2006 to Merck & Co., Inc. for prevention of pediatric rotavirus gastrointestinal disease.
11. Hepatitis B Immune Globulin, i.m./Cangene [Hepatitis B Immune Globulin (Human); HepaGam B]; granted on 1/27/2006 to Cangene Corp. for for post-exposure propylaxis following acute exposure to hepatitis B virus.
12. Insulin, rDNA, inhaled/Pfizer [Exubera Insulin, recombinant powder for inhalation]; granted on 1/27/2006 to Pfizer, Inc. for the treatment of adults with type 1 and type 2 diabetes.
13. Immune globulin (SCIG) [Vivaglobin]; granted on 1/9/2006 to ZLB Behring for treatment of primary immunodeficiency.

2005

1. CTLA4-Ig, rDNA [Orencia; Abatacept; cytotoxic T-lymphocyte- associated antigen 4--Immunoglobulin G1 fragment fusion protein, recombinant; BMS-188667] granted on 12/26/2005 to Bristol-Myers Squibb Co. for second-line treatment of rheumatoid arthritis in moderate to severe adult patients.
2. Insulin-like Growth Factor-1/IGFBP-3, rDNA [Mecasermin rinfibate - IPLEX; SomatoKine; nsulin-like growth factor I--insulin-like growth factor-binding-3 protein complex, recombinant; IGF-1/IGFBP3 complex] granted on 12/12/2005 to Insmed Inc. for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.
3. Hyaluronidase, rDNA [Hylenex; Enhanze SC; Cumulase; Chemophase; rHuPH20; PH-20 hyaluronidase, recombinant human] approval of Hyelex (formerly Enhanze SC) granted on 12/5/2005 to Halozyme Therapeutics Inc. for marketing by Baxter for use as a "spreading agent" to enhance the delivery of local anesthesia, contrast agents, and for subcutaneous fluid replacement (hypodermoclysis).
4. Hyaluronidase, ovine/Primapharm [Hydase] granted on 10/25/2005 to PrimaPharm, Inc. for use as a "spreading agent" to enhance the delivery of local anesthesia, contrast agents, and for subcutaneous fluid replacement (hypodermoclysis).
5. PDGF, rDNA/Bone matrix [Platelet-derived growth factor (PDGF)-BB, recombinant with inorganic bone matrix; rhPDGF-BB; GEM 21S] granted on 10/21/2005 to BioMimetic Therapeutics, Inc. for marketing by Osteohealth Co. (Luitpold Pharmaceuticals, Inc., Sankyo Co., Ltd.) for the treatment of periodontal bone defects and associated gingival recession.
6. Measles Mumps Rubella & Varicella Vaccine [Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live - ProQuad; M-M-R II plus Varivax vaccine] granted on 9/6/2005 to Merck & Co., Inc. for vaccination against measles, mumps, rubella (German measles) and varicella (chickenpox) in children 12 months to 12 years of age
7. Influenza Vaccine/GSK Canada [Influenza Virus Vaccine, Trivalent, Types A and B - Fluarix]; granted on 8/31/2005 to GlaxoSmithKline Biologicals for prevention of influenza
8. Influenza vaccine/GSK Germany [Influenza Virus Vaccine, Trivalent - Fluarix; Influsplit SSW; Alpharix]; granted on 8/31/2005 to Sachsische Serumwerke AG for marketing by GlaxoSmithKline for prevention of influenza.
9. Insulin-like Growth Factor-1, rDNA/Tercica [Insulin-like Growth Factor-1, recombinant - Increlex; IGF-1] granted on 8/31/2005 to Tercica, Inc. (partnered with Genentech) for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone
10. Calcitonin, rDNA [Calcitonin (salmon) - Fortical; calcitonin, recombinant] granted on 8/15/2005 to Unigene, Inc. (marketed by Upsher-Smith Labs.) for the treatment of postmenopausal osteoporosis
11. Insulin detemir, rDNA - [Insulin detemir, recombinant - Levemir] granted on 6/17/2005 to Novo Nordisk Inc. for the treatment of diabetes mellitus (type 1 and type 2; [a long-acting recombinant insulin analog]
12. dTpa booster/Sanofi [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed - Adacel; dTpa; Tdap] granted on 6/10/2005 to Aventis Pasteur Ltd. for use as a tetanus, diptheria and pertussis (whooping cough) booster vaccine for those ages 11-64
13. Arylsulfatase B, rDNA [N-acetylgalactosamine 4-sulfatase - Naglazyme; Aryplase; galsulfase; chondroitinase; rhASB (recombinant)] - granted on 5/31/2005 to BioMarin Pharmaceutical Inc. for treatment of mucopolysaccharidosis VI (MPS VI).
14. dTpa booster/GSK [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed - Boostrix; dTpa; Tdap] - granted on 5/3/2005 to GlaxoSmithKline Biologicals S.A. for use as a tetanus, diptheria and pertussis (whooping cough) booster vaccine for those ages 10-18
15. Tetanus Toxoid/Chiron [Tetanus Toxoid Concentrate (For Further Manufacturing Use]; granted on 5/3/2005 to Chiron Behring GmbH & Co. (Chiron Corp.; merging into Novartis AG) for use as a component of Boostrix combination vaccine (see above entry)
16. Vaccinia Immune Globulin, i.v./Cangene [VIG; VIVIG] - granted on 5/3/2005 to Cangene Corp. for treatment of rare complications of smallpox vaccination (systemic, severe skin or other serious infections due to the live vaccinia virus in current smallpox vaccines)
17. Hyaluronidase, rDNA [Cumulase; Enhanze SC; Chemophase; rHuPH20; PH-20 hyaluronidase, recombinant human] - device approval of Cumulase on 4/19/2005; granted to Halozyme Therapeutics, Inc. for use in in vitro fertilization (IVF) procedures (preparation of oocytes prior to in vitro fertilization)
18. Vaccinia Immune Globulin, i.v./DVC [VIG; VIGIV] - granted on 2/18/2005 to DynPort Vaccine Co. LLC for treatment of rare complications of smallpox vaccination (systemic, severe skin or other serious infections due to the live vaccinia virus in current smallpox vaccines)
19. Thrombin, conc. [Thrombin (Human) (For Further Manufacturing Use)] - granted on 2/18/2005 to Baxter Healthcare Corp. for further manufacture of FloSeal Matrix Hemostatic Sealant, used to control bleeding
20. Meningococcal Conjugates Vaccine [Menactra; Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; MCV-4] - granted on 1/14/2005 to Sanofi Pasteur Inc. for protection against meningococcal disease in adolescents and adults aged 11-55 years

2004:

1. VEGF apatamer, PEG - [Pegaptanib sodium - Macugen; vascular endothelial growth factor/vascular permeability factor (VEGF) aptamer, synthetic oligonucleotide, PEGylated)] granted on 12/17/2004 to Eyetech Pharmaceuticals, Inc. for treatment of neovascular (wet) age-related macular degeneration [synthetic 28-mer oligonucleotide, mimics a VEGF antibody; not a biopharmaceutical].
2. Keratinocyte growth factor, rDNA* [Palifermin - Kepivance; des1-23 KGF; 24-163 fibroblast growth factor 7 (human)] granted on 12/15/2004 to Amgen Inc. for treatment of severe oral mucositis (mouth sores) in patients with hematologic cancers undergoing high-dose chemotherapy, followed by a bone marrow transplant.
   
3. Integrin Mab, rDNA [Tysabri - natalizumab; Antegren; integrin alpha(4) humanized monoclonal antibody] granted on 11/24/2004 to Biogen Idec for treatment of multiple sclerosis [formerly Antegren (trade name), now Tysabri; changed at FDA request].
   
4. Hyaluronidase, bovine/Amphastar - [Hyaluronidase, bovine - Amphadase] granted on 10/24/2004 to Amphastar Pharmaceuticals, Inc. for use as a "spreading agent," e.g., as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.
5. Enfuvirtide, synthetic [T-20; Fuzeon; pentafuside; DP-178] full approval (upgraded from accelerated approval granted 3/2003) granted on 10/15/2004 to Hoffmann-La Roche Inc. for the treatment of HIV-1 infection in in combination with other antiretroviral agents in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy [synthetic peptide, not a biopharmaceutical].
6. CD15 Mab-Tc 99m radioconj. [Technetium (99m Tc) fanolesomab; Neutrospec; Leutech; TC99M-labeled CD15 monoclonal antibody] - granted on 7/2/2004 to Palatin Technologies, Inc. for diagnostic imaging of appendicitis (scintigraphic imaging of patients with equivocal signs of appendicitis who are five years of age or older.)
7. Luteinizing hormone, rDNA [Lutropin alfa - Luveris; human luteinizing hormone, recombinant] granted to Serono, Inc. on 5/24/204 for infertility treatment [stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound LH deficiency in combination with FSH (Gonal-f)].
8. Immune Globulin (IGIV)/Octapharma [Octagam; Immune Globulin Intravenous (Human)] - granted on 5/21/2004 to Octapharma AG for treatment of primary immune deficiency.
9. Hyaluronidase, ovine [Vitrase; hyaluronate 4-glycanohydrolase] granted on 5/4/2004 to ISTA Pharmaceuticals Inc. for use as a spreading agent to facilitate the dispersion and absorption of drugs, particularly local anesthetics, during ophthalmic surgery; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents
10. Insulin glulisine, rDNA [Apidra; [LysB3, GluB29] insulin; insulin (human), 3B-l-lysine, 29B-l-glutamic acid-, recombinant] - granted on 4/16/2004 to Aventis Pharma for use as a rapid-acting insulin for treatment of diabetes.
11. VEGF Mab, rDNA [Avastin; bevacizumab; vascular endothelial growth factor monoclonal antibody, recombinant] - granted on 2/26/2004 to Genentech, Inc. for use in combination with 5-fluorouracil for treatment of metastatic cancer of the colon or rectum.
12. EGF receptor Mab, rDNA [Cetuximab - Erbitux; IMC-C225; epidermal growth factor receptor monoclonal antibody, recombinant] - granted on 2/12/2004 to ImClone Systems Inc. (for marketing by Bristol-Myers Squibb Co.) for use in combination with irinotecan in the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy, and for monotherapy treatment of patients with EGFR-expressing metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy.
13. Rho(D) Immune Globulin/ZLB [Rho(D) Immune Globulin Intravenous (Human) - Rhophylac] - granted on 2/12/2004 to ZLB Bioplasma AG for antepartum and postpartum prevention of Rho(D) immunization in Rho(D)-negative women.
14. Hyaluronic acid/Anika [ORTHOVISC High Molecular Weight Hyaluronan] - granted on 2/5/2004 to Anika Therapeutics, Inc. for U.S. marketing by Ortho Biotech Products, L.P. (Johnson & Johnson) for the treatment of pain associated with osteoarthritis of the knee. [Derived from rooster combs; considered a borderline biopharmaceutical product]

1. Immune Globulin Intravenous (Human) [Flebogamma] - granted on 12/18/2003 to Instituto Grifols (Probitas Pharma) for treatment of primary immune deficiency.
2. Hyaluronic acid/Medicis [Restylane] - granted on 12/12/2003 to Medicis Pharmaceutical Corp. for correction of moderate to severe facial wrinkles and folds, e.g., nasolabial folds (lines/folds near the nose and mouth). [bacterial fermentation-derived; considered a mainstream biopharmaceutical product]
3. CD11a Mab, rDNA [Efalizumab - Raptiva; CD11a monoclonal antibody, recombinant] - granted on 10/27/2003 to Genentech, Inc. and Xoma Ltd. for the treatment of moderate-to-severe psoriasis in adults who are candidates for systemic or phototherapy.
4. Botulism Immune Globulin Intravenous (Human) [BabyBIG] - granted on 10/23/2003 to the California Department of Health Services for treatment of infant botulism caused by type A or type B Clostridium botulinum.
5. Somatropin, rDNA/Serono [Somatropin (rDNA origin) - Serostim; human growth hormone, recombinant] - full approval granted on 8/29/2003 to Serono Inc. for the treatment of HIV patients with wasting or cachexia [upgraded from accelerated approval granted in 1996]
6. Factor VIII, rDNA, PFM [Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method - Advate; Factor VIII, recombinant; rAHF-PFM] - granted on 7/25/2003 to Baxter Hyland Immuno for treatment of hemophilia A.
7. TNF Receptor-IgG Fc, rDNA [Etanercept - Enbrel; tumor necrosis factor receptor2-immune globlulin G1 Fc fusion protein, recombinant] - supplemental BLA granted on 7/24/2003 to Amgen Inc. for treatment of active ankylosing spondylitis.
8. Antitrypsin, alpha-1/Aventis [Alpha-1-Proteinase Inhibitor (Human) - Zemaira] - granted on 7/8/2003 to Aventis Behring LLC for chronic augmentation and maintenance therapy in individuals with alpha1-proteinase inhibitor deficiency and evidence of emphysema.
9. CD20 Mab, rDNA--I 131 radioconj. [Iodine I 131 tositumomab - Bexxar; CD20 monoclonal antibody--Iodine I 131 radioimmune conjugate] - granted on 6/27/2003 to Corixa Corp g . (formerly Coulter Pharmaceutical) with marketing by GlaxoSmithKline (GSK) for the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma (NHL), with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy.
10. Immunoglobulin E Mab, rDNA [Omalizumab - Xolair; rhuMab-E25; immunoglobulin E25 monoclonal antibody, recombinant; IgE Mab, rDNA] - granted on 6/20/2003 to Genentech, Inc. (with manufacture by Tanox, Inc. and co-marketing by Novartis Pharmaceutical Corp.) for treatment of moderate-to-severe allergic asthma.
11. Hirudin, desulfato- rDNA/Aventis [Iprivask; Desirudin; Revasc; desulfatohirudin; hirudin, desulfato- recombinant] - granted on 4/3/2003 to Aventis Pharma for approved for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in patients undergoing elective hip replacement surgery.
12. Influenza Vaccine, live rDNA, frozen [FluMist] - granted on 6/17/2003 to MedImmune Vaccines, Inc. (subsidiary of MedImmune, Inc.) for influenza prophylaxis in healthy persons from 5-50 year of age.
13. Iduronidase, rDNA [laronidase; Aldurazyme; alpha-L-iduronidase] - granted on 4/30/2003 to Biomarin Pharmaceutical Inc. (and Genyzme Corp.) for treatment of Mucopolysaccharidosis I (MPS I)
14. Galactosidase, beta rDNA [Agalsidase beta - Fabrazyme; alpha-galactosidase A] - granted on 4/24/2003 to Genzyme Corp. for treatment of Fabry disease
15. Somatropin antagonist, PEG-, rDNA [Pegvisomant - Somavert; somatropin antagonist, pegylated, recombinant] - granted on 3/25/2003 to Pharmacia Corp. for treatment of acromegaly
16. Enfuvirtide, synthetic [T-20; Fuzeon; pentafuside; DP-178] - granted on 3/15/2003 to Hoffmann-La Roche Inc. for treatment of HIV-infection [synthetic; not a biopharmaceutical]
17. LFA-3/IgG1, rDNA [Alefacept; Amevive; leukocyte function-associated antigen-3/immune globulin G (IgG) fusion protein, recombinant] - granted on 1/30/2003 to Biogen Corp. for treatment of moderate-to-severe chronic plaque psoriasis
18. Antitrypsin, alpha-1/Baxter [alpha-1 Proteinase Inhibitor (Human); Aralast; alpha-1 antitrypsin; AAT; A1P1] - granted on 1/9/2003 to Alpha Therapeutic Corp. (for marketing by Baxter) for enzyme replacement therapy in patients with heredity emphysema (AAT deficiency)

2002:

1. TNF Mab, rDNA, human [Adalimumab; Humira; D2E7; tumor necrosis factor-alpha human monoclonal antibody] - granted on 12/30/2002 to Abbott Laboratories for treatment of rheumatoid arthritis
2. DTaP & Hepatitis B & Polio Vaccine [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined; Pediarix; Infanrix + Engerix-B + IPOL] - a combination vaccine; approval granted on 12/13/2002 to GlaxoSmithKline Inc. for prevention of diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio; Poliovirus vaccine (mixture of three inactivated strains) is the only component not previously approved.
3. Parathyroid hormone (1-34), rDNA [teriparatide (rDNA origin); Forteo; LY333334; parathyroid hormone (1-34), recombinant] - granted on 11/26/2002 to Eli Lilly & Co. for treatment of osteoporosis
4. Interferon alfa-2a, rDNA, PEG- [Peginterferon alfa-2a; Pegasys; interferon alpha-2a, recombinant, pegylated] - granted on 10/16/2002 to Hoffmann-La Roche Inc. for first-line treatment of chronic hepatitis C
5. Urate oxidase, rDNA [uric acid oxidase, recombinant; rasburicase; re-Uox; Elitek; Fasturtec] - granted on 7/16/2002 to Sanofi-Synthelabo for control of plasma uric acid levels (hyperuricaemia) in pediatric patients receiving cancer chemotherapy resulting in tumor lysis and elevation of uric acid
6. Bone morphogenic protein-2, rDNA [bone morphogenetic protein-2, recombinant; BMP-2; INFUSE Bone Graft] - PMA granted on 7/2/2002 to Medtronic Sofamor Danek using recombinant bmp-2 (from Genetics Institue/Wyeth) as part of the INFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device for treatment of certain types of spinal degenerative disc disease (lumbar spinal fusion)
7. DTaP Vaccine/Aventis Canada Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) [DAPTACEL] - BLA granted on 5/14/2002 to Aventis Pasteur, Ltd. for the first 4 doses of the diphtheria and tetanus toxoids and pertussis vaccination series administered to infants and children aged 6 weeks up to 7 years
8. Botulinum Toxin Type A Purified Neurotoxin Complex [BOTOX COSMETIC] - supplemental BLA granted on 4/12/2002 to Allergan, Inc. for temporary improvement in the appearance of moderate to severe glabellar lines ["frown lines"] associated with corrugator and/or procerus muscle activity in adult patients < 65 years of age
9. Secretin, synthetic [SecreFlo; porcine secretin] - not a biopharmaceutical product (synthetic); granted on 4/5/2002 to Repligen Corp. for diagnosis of gastrinoma (tumors that secrete gastrin) and pancreatic disorders
10. Interferon beta-1a, rDNA/Serono [Rebif] - granted on 3/7/2002 to Serono, Inc. for treatment of relapsing forms of multiple sclerosis
11. CD20 Mab/Y-90 radioconj. [Ibritumomab Tiuxetan; Zevalin; a CD20 monoclonal antibody-chelating group conjugate] - granted on 2/29/2002 to IDEC Pharmaceuticals Corp. for treatment of B-cell non-Hodgkin's lymphoma; regimen includes Rituximab, Indium-111 Ibritumomab Tiuxetan, and Yttrium-90 Ibritumomab Tiuxetan
12. G-CSF, rDNA, PEG- [Pegfilgrastim; Neulasta; pegylated granulocyte-colony stimulating factor] - granted on 1/31/2002 to Amgen, Inc. for treatment of febrile neutropenia in patients receiving chemotherapy for non-myeloid malignancies

Further Information:

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