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)
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)
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)
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