Company Product Description Indication Status/Date
Abbott Laboratories Norvir capsules (ritonavir) HIV protease inhibitor HIV infection The European Union's Committee for Proprietary Medicinal Products adopted a positive opinion on Norvir (8/10)
Alza Corp. Ditropan XL (oxybutynin; FDAapproved) Oxybutynin chloride extended-release tablets (via OROS osmotic drug-delivery technology) Relief of overactive bladder with symptoms including urge urinary incontinence, urgency and frequency New drug submission accepted for review in Canada (2/8)
Atrix Laboratories Inc. Atridox Biodegradable polymer incorporating 10% doxycycline Periodontal disease Approved for marketing in the UK (4/28)
BioChem Pharma Inc. (Canada) and Glaxo Wellcome plc (UK) Heptodin (a.k.a. lamivudine and Zeffix) Nucleoside analogue (oral dosage) Chronic hepatitis B virus infection Approved for marketing in People's Republic of China (1/9)
BioChem Pharma Inc. (Canada) Zeffix Nucleoside analogue; (oral dosage) Chronic hepatitis B infection Cleared for marketing and launched in South Korea (5/26)
BioChem Pharma Inc. (Canada) Zeffix Lamivudine, nucleoside analogue (oral dosage) Chronic hepatitis B Received marketing approval in the European Union (8/2)
BioChem Pharma Inc. Zeffix Lamivudine; nucleoside analogue (oral dosage) Chronic hepatitis B Approved in Taiwan (11/1)
Biomatrix Inc. Hylaform Injectable hylan B gel tissue augmentation product Correction of facial wrinkles and depressed scars Approved for marketing in Australia (3/19)
Biomatrix Inc. and F. Hoffmann-La Roche Ltd. (Switzerland) Synvisc Elastoviscous hylan biopolymer; chemically modified version of natural hyaluranon Treatment of pain caused by osteoarthritis of the knee Approved for marketing in South Africa (3/30)
Biota Holdings Ltd. and Glaxo Wellcome plc Relenza (Zanamivir for inhalation) Zanamivir; neuraminidase inhibitor (designed and synthesized based on crystal structure of surface proteins of influenza virus); inhaled in powder form Treatment of influenza Approved for marketing in Australia (3/26)
Biopure Corp. Hemopure Hemoglobin glutamer oxygen therapeutic Elimination or reduction of red blood cell transfusions in elective surgeries Received fast-track status from South Africa's Medicines Control Council (8/30)
Biopure Corp. Oxyglobin Hemoglobin glutamer oxygen therapeutic Canine anemia European Commission issued marketing authorization (12/2)
BioTime Inc. Hextend Physiologically compatible blood plasma expander Hypovolemia resulting from surgical procedures and injuries New drug submission accepted by the Canadian Health Protection Branch (11/5)
Cangene Corp. (Canada) Deferiprone Ferriprox Iron-overloading in transfusion-dependent patients with thalassemia major Approved in Europe (8/26)
Cangene Corp. (Canada) VZIG (Varicella zoster immune globulin) Specialized antibody purified from human plasma Prevention of chicken pox during pregnancy Granted fast-track review by the Therapeutic Products Directorate of Health Canada (8/12)
Cangene Corp. (Canada) VZIG (Varicella zoster immune globulin) Specialized antibody purified from specially collected human plasma; reacts with a certain type of red blood cell Prevention of chicken pox during pregnancy Filed new drug submission (7/5)
Cangene Corp. (Canada) WinRho SDF Purified antibody that reacts with a certain type of red blood cell (Rh+ cells) Prevention of hemolytic disease in newborns Received UK marketing approval (7/27)
Celgene Corp. and Biovail Corp. International d-MPH (dmethylphenidate hydrochloride) Chirally pure form of Ritalin Attention deficit hyperactivity disorder Canadian authorities approved investigational new drug application, allowing clinical trials to begin (2/16)
Centocor Inc. and ScheringPlough Corp. Remicade Tumor necrosis factor alpha inhibitor Crohn's disease Granted marketing authorization in the European Union (8/17)
Centocor Inc. and ScheringPlough Corp. Remicade Infliximab; chimeric monoclonal antibody to tumor necrosis factor-alpha Crohn's disease European Union's Committee for Proprietary Medicinal Products recommended approval in Europe (5/24)
Cephalon Inc. Modasomil (Provigil in the U.S.) Modafinil; oral formulation of synthetic compound that is thought to affect alphaadrenergic receptors in the brain Narcolepsy Cleared for marketing in Australia (5/25)
Chiron Corp. Proleukin Aldesleukin; recombinant interleukin-2 Metastatic melanoma Approved for marketing in Canada (2nd indication) (1/8)
Chiron Corp. and Berlex Laboratories Inc. Betaseron Recombinant human interferon beta-1b Secondary progressive multiple sclerosis Approved for marketing by the Commission of the European Communities (1/28)
Chiron Corp. Triacelluvax Diphtheria and tetanus toxoids and acellular pertussis vaccine Prevention of diphtheria, tetanus and acellular pertussis Cleared for marketing by the European Medicines Evaluation Agency; marketing allowed in 15 EMEA member states, except Germany (2/2)
Chiron Corp. and Ortho-McNeil Pharmaceutical Inc. (subidiary of Johnson & Johnson) Regranex Becaplermin; gel form of recombinant human plateletderived growth factor-beta Treatment of fullthickness lowerextremity diabetic ulcers Approved for marketing in Canada (3/1)
Chiron Corp. Agrippal Subunit influenze vaccine Influenza Received national marketing authorizations in most Western European countries (8/2)
Chiron Corp. Macrolin IL-2 Macrophage-colony stimulating factor HIV-infected patients who lack adequate immune reconstitution, despite effective anti-retroviral treatment French Ministry of Health granted authorization for temporary use (9/10)
Chiron Corp. Menjugate Conjugate vaccine Meningococcal C disease Filed marketing application with the UK Medicines Control Agency (9/9)
Ciba Vision Corp. (a unit of Novartis AG, Switzerland) and QLT Phototherapeutics Inc. (Canada) Visudyne Verteporfin; light-activated drug for photodynamic therapy Treatment of wet agerelated macular degeneration (AMD) in patients with predominately classic subfoveal choroidal neovascularization Filed for marketing clearance with the European Medicines Evaluation Agency in the European Union (8/9)
Ciba Vision (a unit of Novartis AG) and QLT PhotoTherapeutics Inc. (Canada) Visudyne Verteporfin; light-activated drug for photodynamic therapy Wet form of agerelated macular degeneration Received marketing aproval from the Swiss regulatory agency Interkantonale Kontrollstelle fur Heilmittel (12/16)
Cor Therapeutics Inc. and Schering-Plough. Corp. Integrilin Eptifibatide; small-molecule compound (derived from rattlesnake venom) that inhibits GPIIb/IIIa receptor that mediates platelet aggregation Prevention of myo cardial infarction in patients presenting with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) The Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products issued a positive opinion recommending approval (3/1)
Corixa Corp. Melacine Melanoma therapeutic vaccine Late-stage melanoma Canadian Health Protection Branch issued a notice of compliance, approving Melacine for sale in Canada (11/4)
Creative BioMolecules Inc. and Stryker Corp. OP-1 Implant Device that combines genetically engineered bone morphogenic protein (OP-1) with resorbable collagen scaffold that is surgically implanted in bone fractures and defects Long bone nonunions Submitted marketing authorization application to European Medicines Evaluation Agency (6/7)
Digene Corp. Hybrid Capture II test for chlamydia and gonorrhea Assay that detects genetic material from Chlamydia trachomatis and Neisseria gonorrhea Detection of chlamydia and/or gonorrhea infection Cleared for marketing in Brazil and Argentina (4/29)
Digene Corp. Hybrid Capture II test for human papillomavirus Assay that detects DNA from 18 different human papillomavirus types Detection of human papillomavirus infection Cleared for marketing in Brazil and Argentina (4/29)
Enzon Inc. and Schering Plough Corp. Peg-Intron Long-acting dosage form of Intron A (recombinant interferon alfa-2b) conjugated to polyethylene glycol Chronic hepatitis C Submitted MAA to the EMEA (11/9)
Genzyme General (division of Genzyme Corp.) Seprafilm Bioresorbable Membrane Bioresorbable membrane that prevents fibrin, unleashed as the result of surgical insult, from building the scaffolding needed for adhesions Reduction of incidence of adhesions following cardiac urgery Received CE Mark approval, permitting European Union marketing (2/10)
Gilead Sciences Inc. Adefovir dipivoxil 60 mg An oral nucleotide reverse transcriptase inhibitor HIV infection Marketing authorization application accepted by the European Medicines Evaluation Agency (EMEA) (10/25)
Hemispherx Biopharma Inc. Ampligen Double-stranded synthetic RNA compound poly I:poly C12U Chronic fatigue syndrome (a.k.a. myalgic encephalomyelitis) European Union marketing application cleared first stage of regulatory review (2/4)
ICN Pharmaceuticals Inc. and Schering-Plough Corp. Rebetron Combination of Intron A (recombinant human interferon alfa-2b; injection) and Rebetol (ribavirin) Previously untreated adult hepatits C infection Cleared for marketing in Canada (5/3)
ICN Pharmaceuticals Inc. and Schering-Plough Corp. Rebetron Combination of Intron A (recombinant human interferon alfa-2b; injection) and Rebetol (ribavirin) Previously untreated adult hepatits C infection Cleared for marketing in European Union (5/10)
Immunomedics Inc. CEA-Scan Fragment of murine monoclonal antibody to tumor marker carcinoembryonic antigen (CEA), labeled with technetium-99m In vivo nuclear imaging agent for breast cancer (in women with abnormal mammograms) Submitted marketing application to European Medicines Evaluation Agency (1/26)
Integra LifeSciences Corp. Helistat and Helitene Hemostatic agents; Helistat is absorbable collagen hemostatic sponge designed to promote platelet aggregation; Helitene is absorbable collagen hemostatic agent in fibrillar form To help control bleeding in cardiovascular, neurosurgical and general surgical procedures Received CE Mark certification in European Union (1/27)
Integra LifeSciences Corp. DuraGen Dural Graft Matrix Collagen matrix for the restoration of the dural membrane; provides a scaffold for the infiltration of fibroblasts and a substrate for the deposition of new collagen Method of dural closure in neurological procedures Received CE Mark Certification, permitting marketing in 18 European Union member states (2/4)
Isis Pharmaceuticals and CibaVision Corp. (a unit of Novartis AG; Switzerland) Vitravene Antisense inhibitor of cytomegalovirus retinitis (CMV) CMV in patients with AIDS Received marketing approval in the European Union (8/4)
Ivax Corp. Paxene Paclitaxel; compound extracted from needles and limb stock of ornamental yew trees AIDS-related Kaposi's sarcoma European Committee for Proprietary Medicinal Products recommended approval (1/28)
Ligand Pharmaceuticals Inc. Panretin Gel Alitretinoin 0.1% (topical); chemically synthesized version of 9-cis-retinoic acid (derived from vitamin A) Treatment of dermal lesions in AIDS-related Kaposi's sarcoma Submitted marketing authorization application to the European Agency for the Evaluation of Medicinal Products (2/8)
Ligand Pharmaceuticals Inc. Targretin capsules Bexarotene; synthetic retinoid X receptors; oral formulation Cutaneous T-cell lymphoma Submitted marketing authorization application to the European Medicines Evaluation Agency (12/1)
Nabi Nabi-HB Hepatitis B human immune globulin Hepatitis B Filed a new drug submission with Canadian regulatory authorities (10/21)
Neoprobe Corp. NEO 2000 Hand-held isotope detector (gamma detection system) For use in intraoperative lymphatic mapping (surgical detection and management of cancer) Received CE Mark certification in European Union (1/29)
Nexell Therapeutics Inc. (formerly Vimrx Pharmaceuticals Inc.) and Baxter International Isolex 300 and Isolex 300i Stem-cell selection systems; devices that separate CD34+ stem cells from peripheral blood (Isolex 300 is semi-automated; Isolex 300i is fully automated) Stem cell selection Cleared for marketing in Canada (5/19)
North American Vaccine DTap-IPV Combines Certiva, a DTaP vaccine, with injectable, inactivated polio vaccine Prevention of diphtheria, tetanus, acellular pertusis and polio Approved for marketing in Germany (2/1)
Novo Nordisk A/S (Denmark) NovoRapid Insulin aspart; rapid-acting, self-injected insulin analogue Diabetes mellitus European Union's Committee for Proprietary Medicinal Products recommended approval (5/25)
Orphan Medical Inc. and Cambridge Laboratories (UK) Antizol Injection Fomepizole (4-methylpyrazole); synthetic alcohol dehydrogenase inhibitor Antidote for suspected or confirmed ethylene glycol (antifreeze or coolant) poisoning Cleared for marketing in the UK (6/25)
PathoGenesis Corp. TOBI Tobramycin for inhalation Chronic lung infection (with Pseudomonas aeruginosa) in cystic fibrosis patients Cleared for marketing in Canada and Argentina (2/16)
PathoGenesis Corp. TOBI Tobramycin solution for inhalation; aerosolized antibiotic Cystic fibrosis patients with chronic pulmonary Pseudomonas aeruginosa Approved and launched in Canada (5/11)
PathoGenesis Corp. TOBI Tobramycin; 300 mg nebulizer solution Chronic pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis patients UK Department of Health granted marketing authorization (12/15)
QLT PhotoTherapeutics Inc. (Canada) Photofrin Photosensitive drug (porfimer sodium; produces toxic oxygen compound when light-activated) Palliative treatment of advanced lung and esophogeal cancer Cleared for marketing in Finland (2/25)
QLT PhotoTherapeutics Inc. and Ciba Vision Corp. (a unit of Novartis AG) Visudyne Verteporfin; light-activated drug for photodynamic therapy Wet age-related macular degeneration Filed for approval with the Canadian Therapeutics Products Programme (11/4)
SangStat Medical Corp. SangCya (formerly Sang-35) Cyclosporine (oral formulation; buioequivalent to Neoral oral solution) Prevention of rejection in solid organ transplant recipients, as well as other immunosuppressant indications Cleared for marketing in the UK (2/4)
SciClone Pharmaceuticals Inc. Zadaxin (thymosin alpha 1) Synthetic version of naturally occurring peptide hormone thymosin (immunomodulator) Chronic hepatitis B virus and hepatitis C virus infections Approved for marketing in Venezuela (1/5)
SciClone Pharmaceuticals Inc. Zadaxin (thymosin alpha 1) Synthetic version of naturally occurring peptide hormone thymosin (immunomodulator) Hepatitis B virus infection Cleared for marketing in Vietnam (3/17)
SciClone Pharmaceuticals Inc. Zadaxin (thymosin alpha 1) Synthetic version of naturally occurring peptide hormone thymosin (immunomodulator) Hepatitis C virus infection Label expanded in Singapore to include hepatitis C infection, in addition to hepatitis B (3/17)
SciClone Inc. Zadaxin (thymosin alpha 1) Thymosin alpha 1; synthetic version of naturally occurring peptide hormone thymosin (immunomodulator) Hepatitis B infection Cleared for marketing in Malaysia (5/27)
SciClone Pharmaceuticals Zadaxin (thymosin alpha 1) Thymosin alpha 1; synthetic version of naturally occurring peptide hormone thymosin Hepatitis B Received marketing approval in Brunei and Sri Lanka (8/16)
Teva Pharmaceuticals Industries Ltd. (Israel) Copaxone Glatiramer acetate for injection Relapsing-remitting multiple sclerosis Cleared for marketing in Switzerland (5/11)
The Liposome Co. Inc. Abelcet Amphotericin B lipid complex (injection) Systemic fungal infections (2nd-line therapy) Approved for marketing in the Netherlands (1/12)
The Liposome Co. Inc. Evacet Liposomal formulation of doxorubicin Metastatic breast cancer (combination therapy with cyclophosphamide) Filed new drug Submission with the Therapeutic Products Programme for marketing approval in Canada (7/7)
The Liposome Co. Inc. Evacet Liposomal formulation of doxorubicin Treatment of metastatic breast cancer, either alone or in combination with cyclophosphamide European Medicines Agency accepted the filing of Evacet for marketing clearance in the European Union (8/10)
The Liposome Co. Inc. Abelcet injection Complex of amphotericin B with two phospholipids Invasive fungal infections in patients intolerant of conventional amphotericin B Received regulatory approval in Belgium (8/24)
The Liposome Co. Inc. Abelcet Amphotericin B lipid complex (injection) Invasive fungal infections in patients refractory to or intolerant of conventional amphotericin B therapy Received marketing approval in Turkey (11/2)
The Medicines Co. Bivalirudin Anticoagulant therapeutic that directly inhibits thrombin, a key component in blood clot formation and extension Patients undergoing coronary angioplasty Received marketing approval in New Zealand (10/25)
Unigene Laboratories Inc. Forcalcitonin Recombinant salmon calcitonin (injection) Paget's disease; also hypercalcemia associated with malignancy Approved for marketing in all 15 member states of European Union (1/19)
U.S. Bioscience and Schering-Plough Corp. Ethyol Amifostine; selective cytoprotective agent Prevention of acute and late xerostomia in headand-neck cancer Cleared for marketing in Europe (4/29)
Vertex Pharmaceuticals Inc. and Kissei Pharmaceutical Co. (Japan) Prozei (amprenavir) Orally administered HIV protease inhibitor HIV-infected patients Kissei filed for marketing approval in Japan (7/2)
Vivus Inc. Muse Alprostadil; prostaglandin E1 Erectile dysfunction Received marketing license in Spain (8/27)