Advanced Magnetics Inc. and Eiken Chemical Ltd. (Japan)
Feridex
MRI contrast agent
Detection of liver lesions
Cleared for marketing in Japan (7/14)
Advanced Tissue Sciences Inc. and Smith & Nephew plc (U.K.)
Dermagraft
Human tissue-engineered replacement for dermal layer of skin (living tissue)
Wound healing in diabetic foot ulcers
Cleared for marketing in Canada (8/18)
Agouron Pharmaceuticals Inc.
Viracept
Synthetic small molecule designed to inhibit HIV protease
HIV infection in adults and children
Submitted Marketing Authorization Application (MAA) to European Medicines Evaluation Agency (2/19)
Aronex Pharmaceuticals Inc.
Nyotran
Lipid-based, intravenous formulation of nystatin
Systemic fungal infections
Filed marketing authorization application in Spain (12/19)
Atrix Laboratories Inc.
Atridox
Biodegradable polymer incorporating doxycycline
Periodontal disease
Submitted marketing application to the U.K.¿s Medicines Control Agency (10/14)
Baxter Healthcare Corp. (unit of Baxter International Inc.)
HemAssist
Diaspirin cross-linked hemoglobin (purified from outdated human donor blood)
Alternative to blood in cardiac surgery patients following cardiopulmonary bypass surgery
Application for marketing authorization was accepted for filing by European Medicines Evaluation Agency (5/6)
BioChem Pharma Inc. (Canada) and Glaxo Wellcome plc (U.K.)
Combivir
Combination of anti-retroviral drugs 3TC/ Epivir (Lamivudine) and AZT (Retrovir) in single tablet
HIV infection and AIDS
European Union¿s Committee for Proprietary Medicinal Products recommended approval (11/21)
Biogen Inc.
Avonex
Recombinant human interferon beta-1a
Relapsing multiple sclerosis
European Commission approved product for marketing in all 15 member countries of European Union (3/17)
Biomatrix Inc.
Hylaform
Hylan B gel tissue augmentation product
Correction of facial wrinkles and depressed scars
Cleared for marketing in Canada and Israel (12/31)
Biomatrix Inc.
Synvisc
Elastoviscous hylan biopolymer; chemically modified version of natural hyaluronan
Osteoarthritis of the knee
Approved for marketing in People¿s Republic of China (4/11)
Biomira Inc. (Canada)
Tru-Scint AD
Technetium-99m-labeled monoclonal antibody that reacts with most adenocarcinomas
In vivo imaging agent for detecting recurrent breast cancer and primary residual or recurrent ovarian cancer
The company dropped efforts to win expedited approval in Canada in light of the Health Protection Branch¿s advisement that insufficient data was available on the statistical significance of a key endpoint (12/1)
Biora AB (Sweden)
Emdogain
Gel formulation containing a porcine protein that mimics the human protein amellogenin, or enamel matrix derivative
Periodontal flap surgery; promotes the growth of tooth-supporting tissues and reattachment of the tooth
Cleared for marketing in Canada (8/25)
Biora AB (Sweden)
Emdogain
Gel formulation containing a porcine protein that mimics the human protein amellogenin, or enamel matrix derivative
Periodontal flap surgery; promotes the growth of tooth-supporting tissues and reattachment of the tooth
Received marketing approval in South Africa (6/30)
Bristol-Myers Squibb Co.
Taxol (Paclitaxel)
Semisynthetic taxane; inhibits cancer cell division by blocking microtubule assembly/disassembly; derived from needles and twigs of yew tree
Advanced ovarian cancer
Cleared for marketing in Japan (7/17)
British Biotech plc (U.K.)
Zacutex (a.k.a. Lexipafant)
Platelet activating factor antagonist (synthesized small drug)
Acute pancreatitis
Submitted Marketing Authorization Application (MAA) to European Med- icines Evaluation Agency (3/5)
Cel-Sci Corp.
Multikine
Natural mixture of human cytokines, including interleukin-2
Squamous cell carcinoma of the head and neck
Received regulatory approval to launch a Canadian clinical trial (6/10)
Centocor Inc. and Eli Lilly and Co. (NYSE:LLY)
ReoPro
Chimeric monoclonal antibody fragment to GPIIb/IIIa platelet receptor
Adjunctive therapy to be used 18-24 hours prior to any percutaneous coronary intervention (to prevent cardiac ischemic complications in broad range of patients, including those with unstable angina not responding to normal therapy)
Approved for marketing in the U.K. (11/25)
Cephalon Inc. and Chiron Corp.
Myotrophin
Recombinant human insulin-like growth factor (IGF-1)
Amyotrophic lateral sclerosis
Companies filed joint marketing authorization application with European Medicines Evaluation Agency; application has been accepted for review (5/14)
Cephalon Inc.
Provigil
Modafinial; oral formulation of synthetic compound that is thought to affect alpha-adrenergic receptors in the brain
Narcolepsy
Approved for marketing in U.K. (10/20)
Chiron Corp. and Ligand Pharmaceuticals Inc.
Proleukin
Recombinant human interleukin-2
Malignant melanoma
Chiron submitted application in Canada for approval of additional indication (8/6)
Chiron Vision (unit of Chiron Corp.)
Vitrasert
Intraocular implant that contains ganciclovir embedded in polymer-based system for slow release of drug
Cytomegalovirus retinitis infection in AIDS patients (as 1st-line therapy)
European Commission granted marketing appro- val in all 15 countries of European Union (3/25)
Chiroscience Group plc (U.K.)
Chirocaine (levobupivacaine)
Bupivacaine derivative
Long-acting anaesthetic
Submitted European Marketing Authorization Application using Sweden as the reference state (12/4)
CollaGenex Pharmaceuticals Inc. and Boehringer Mannheim Italia (unit of Boehringer Mannheim; Germany)
Periostat
Sub-antibiotic dose of oral doxycycline
Adjuvant therapy for periodontal disease; inhibits chronic progressive degradation of periodontal tissue
Boehringer Mannheim Italia submitted a marketing approval application in Italy (7/21)
Columbia Laboratories Inc. and Wyeth-Ayerst (division of American Home Products Corp.)
Small molecule com- pound (derived from rattlesnake venom) that inhibits GPIIb/IIIa receptor that mediates platelet aggregation
To reduce death, heart attack and other complications of percutaneous transluminal coronary angioplasty (as adjunct therapy)
Withdrew application for European marketing approval (4/11)
Cortecs International Ltd. (U.K.)
Macritonin
Oral formulation of salmon calcitonin (a peptide hormone that inhibits bone resorption)
To inhibit breakdown of bone in post-menopausal osteoporosis
Filed for regulatory approval in Ireland (8/29)
Cortecs International Ltd. (U.K.)
Macritonin
Oral formulation of salmon calcitonin (a peptide hormone that inhibits bone resorption)
To inhibit breakdown of bone in post-menopausal osteoporosis
Filed for regulatory approval in Finland (9/11)
Cytogen Corp.
Quadramet
Samarium 153-EDTMP (complex of radioactive samarium and a tetraphosphonate chelator EDTMP)
Treatment of severe pain associated with cancers that have spread to bone
Submitted new drug submission (NDS) in Canada (3/10)
DepoTech Corp.
DepoCyt
Injectable, sustained release formulation of chemotherapeutic agent cytarabine (uses Depo-Foam, lipid-based drug delivery)
Neoplastic meningitis arising from solid tumors
Filed new drug submission in Canada (9/3)
Diatide Inc. and Nycomed Imaging A/S (Norway)
AcuTect
Synthetic peptides, designed to attach to targeted disease molecules, labeled with technetium-99m
In vivo imaging agent for acute deep vein thrombosis
Nycomed submitted application for marketing approval to European Medicines Evaluation Agency (11/20)
Enzon Inc. and Rhone-Poulenc Rorer Canada Inc. (subsidiary of the Rhone-Poulenc Group; France)
Oncaspar
L-asparaginase modified via PEG (polyethylene glycol) technology
1st-line therapy in patients who were diagnosed with acute lymphoblastic leukemia during childhood; also for use in patients who are hypersensitive to native asparaginase
Approved for marketing in Canada (11/19)
Genzyme Corp.
Seprafilm
Bioresorbable membrane, mainly composed of chemically modified hyaluronic acid
To reduce post-surgical adhesions following open abdominal or pelvic surgery
Approved for marketing in Japan (9/3)
Gilead Sciences Inc. and Pharmacia & Upjohn Inc.
Vistide
Cidofovir intravenous; nucleotide analogue that inhibits viral replication
Cytomegalovirus reti- nitis in AIDS patients (both newly diagnosed and relapsing)
Approved for marketing in all 15 countries of the European Union (5/1)
Hoffmann-La Roche Ltd. (unit of Roche Holding Ltd.; Switzerland)
IDEC-C2B8
Genetically engineered chimeric pan-B antibody that targets CD20 anti- gen on B-cell surface
Single-agent therapy for treating relapsed low- grade or follicular non- Hodgkin¿s lymphoma
Submitted Marketing Authorization Applica- tion (MAA) to European Medicines Evaluation Agency (EMEA) (3/3)
Hyal Pharma- ceutical Corp. (Canada)
Solarase
3 0iclofenac gel
Actinic keratosis
Cleared for marketing in the U.K. (7/2)
Idec Pharma- ceuticals Corp. and Hoffmann- La Roche Ltd. (unit of Roche Holding Ltd.; Switzerland)
MabThera (a.k.a. Rituxan)
Rituximab; genetically engineered chimeric pan-B monoclonal anti- body that targets CD20 antigen on B-cell surface
Relapsed or refractory low-grade or follicular non-Hodgkin¿s lymphoma (single-agent therapy)
Approved for marketing in Switzerland (11/28)
Immunex Corp.
Generic paclitaxel
Inhibits cancer cell division by blocking microtubule assembly/disassembly; extracted from all parts of 5- to 7-year-old cultivars of Pacific yew trees (bulk prod- uct made by Hauser Inc.)
Cancer
Cleared for marketing in Canada (7/8)
Immunomedics Inc.
LeukoScan
Antibody fragment that binds to white blood cells, labeled with technetium-99m
In vivo diagnostic imag- ing agent for detecting and diagnosing osteo- myelitis in diabetic pat- ients with foot ulcers
European Commission cleared product for mar- keting in all 15 nations of the European Union (2/14)
Immunomedics Inc.
CEA-Scan
Fragment of murine monoclonal antibody to tumor marker carcino- embryonic antigen (CEA), labeled with technetium-99m
Nuclear imaging in vivo test for recurrent and metastatic breast cancer
Approved for marketing in Canada (9/18)
Imutec Pharma Inc. (Canada)
Virulizin
Biological response modifier extracted from bovine reticulo- endothelium; activates macrophages
Malignant melanoma
Approved for marketing in Mexico (10/21)
Integra Life- Sciences Corp.
Integra Artificial Skin
Product consists of bovine tendon-derived implantable matrix with an outer layer of a silicone-based substitute for epidermis
Wound-healing in burns
Approved for marketing in Taiwan (10/13)
Integra LifeSciences Inc.
Integra Artificial Skin
Product consists of bovine tendon-derived implantable matrix with an outer layer of a silicone-based substitute for epidermis
Permanent dermal replacement for use in burns and surgical pro- cedures
Approved for marketing in China (12/8)
The Liposome Co.
Abelcet
Amphotericin B lipid complex (injection)
1st-line treatment of systemic Candida infections; also 2nd-line treatment of severe sys- temic fungal infections
Product received techni- cal approval for market- ing in Italy and Austria (1/8)
The Liposome Co.
Abelcet
Amphotericin B lipid complex (injection)
1st-line treatment of systemic Candida infections
Approved for marketing in Spain (2/4)
The Liposome Co.
Abelcet
Amphotericin B lipid complex (injection)
Treatment of systemic fungal infections; as a 1st-line therapy for patients whose renal fun- ction precludes use of amphotericin B; as a 2nd-line therapy for patients with aspergil- losis
Approved for marketing in France (3/3)
The Liposome Co.
Abelcet
Amphotericin B lipid complex (injection)
1st-line treatment of candidiasis; 2nd-line treatment of severe systemic fungal infections
Approved for marketing in Switzerland (5/15)
The Liposome Co.
Abelcet
Amphotericin B lipid complex (injection)
Aspergillosis in patients who have failed or who are intolerant of conven- tional amphotericin B therapy (i.e., 2nd-line therapy)
Cleared for marketing in Canada (7/1)
The Liposome Co.
Abelcet
Amphotericin B lipid complex injection
Treatment of severe, in- vasive fungal infections in patients who have not responded to conven- tional amphotericin B or where the use of am- photericin B is contrain- dicated
Cleared for marketing in Norway (12/29)
Matrix Pharmaceutical Inc.
AccuSite Injectable Gel
Delivers chemotherapeutic fluorouracil directly via a sustained-release formulation (biodegradable protein matrix containing 5-FU and epinephrine)
Genital warts
Recommended for market- ing authorization in Belgium, Finland, Ireland, Denmark, Luxembourg and the Netherlands through the European Union¿s mutual recogni- tion process (6/3)
Matrix Pharmaceutical Inc.
AccuSite Injectable Gel
Formulation for local- ized, sustained drug release (biodegradable protein matrix contain- ing 5-FU and epinephrine)
Treatment of external genital warts
Approved for marketing in Ireland and the Nether- lands (9/3)
MedImmune Inc.
CytoGam
Intravenous immune globulin enriched in antibodies to cytomegalovirus
Attenuation of primary cytomegalovirus infection associated with kidney transplantation
Cleared for marketing in Canada (8/6)
MedImmune Inc.
RespiGam
Polyclonal antibody to respiratory syncytial virus (RSV) extracted and pur- ified from human plasma
Prevention of serious lower respiratory tract infection caused by RSV in children under 2 with bronchopulmonary dysplasia or who were born prematurely
Cleared for marketing in Canada (8/21)
Molecular Biosystems Inc. and Mallinckrodt Inc. (NYSE:MKG)
FS069
2nd-generation ultra- sound contrast agent
Diagnostic for use in echocardiography
Submitted Marketing Authorization Appli- cation (MAA) with European Medicines Evaluation Agency (3/6)
Neoprobe Corp.
RIGScan CR49
Radioimmunoguided surgery in which patient is injected with 125-I- labeled monoclonal antibody specific to patient¿s own cancer; surgeon uses gamma radiation-detecting probe to locate target during surgery
Surgical detection of metastatic colorectal cancer
Approved for marketing in South Korea (1/13)
Neoprobe Corp.
RIGScan CR49
Radioimmunoguided surgery in which patient is injected with 125-I- labeled monoclonal anti- body specific to patient¿s own cancer; surgeon uses gamma radiation-detect- ing probe to locate target during surgery
Surgical detection and management of primary and metastatic colorectal cancer
European Agency for Evaluation of Medicinal Products recommended that company withdraw current marketing appli- cation and file a new one (more information requi- red) (11/20)
NeXstar Pharmaceuticals Inc.
AmBisome
Liposomal formulation of amphotericin B
Treatment of systemic fungal infections (as 2nd-line therapy)
Approved for marketing in Switzerland (1/7)
NeXstar Pharmaceuticals Inc.
DaunoXome
Liposomal formulation of daunorubicin
Primary therapy for advanced AIDS-related Kaposi¿s sarcoma
Approved for marketing in Switzerland (1/7)
NeXstar Pharmaceuticals Inc.
AmBisome
Liposomal formulation of amphotericin B
Treatment of systemic fungal infections
Approved for marketing in Brazil (5/21)
NeXstar Pharmaceuticals Inc.
DaunoXome
Liposomal formulation of daunorubicin
Kaposi¿s sarcoma
Approved for marketing in Russia (8/4)
NeXstar Pharmaceuticals Inc.
AmBisome
Liposomal formulation of amphotericin B
1st-line treatment in adults and infants for treatment of severe fungal infections, including fever of unknown origin
Cleared for marketing in Russia (8/4)
NeXstar Pharmaceuticals Inc.
AmBisome
Liposomal formulation of amphotericin B
1st-line treatment for systemic fungal infections and visceral leishmaniasis in adults and infants
Cleared for marketing in South Korea (8/6)
North American Vaccine Inc.
Monovalent acellular pertussis vaccine
To vaccinate children and adolescents against pertussis (whooping cough); includes those who have been vaccinated against diphtheria and tetanus but are still at risk for pertussis
Approved for marketing to broader population in Sweden (expanded label) (4/21)
Organogenesis Inc. and Novartis AG (Switzerland)
Apligraf
Living human skin equi- valent; consists of human keratinocytes and fibro- blasts
Venous stasis ulcers
Approved for marketing in Canada (4/7)
Penederm Inc.
Avita
Retinoic acid (cream and gel formulations); employs TopiCare liquid polymers for drug delivery
Treatment of acne
Approved for marketing in U.K. (2/13)
Penederm Inc. and Schering-Plough Corp.
Butenafine HCl 1 ream (benzylamine- based compound)
Athlete¿s foot (tinea pedis)
Approved in Canada for marketing over the coun- ter (5/8)
Protein Design Labs Inc. and Hoffmann- La Roche Ltd. (unit of Roche Holding Ltd.; Switzerland)
Zenapax (dacliximab)
Humanized monoclonal antibody (SMART Anti- Tac) that binds to the interleukin-2 receptor on activated T cells
Prevention of organ rejection following kidney transplantation
Photosensitive drug (produces toxic oxygen compound when light- activated)
Reduction of obstruction and palliation of symp- toms in patients with ob- structing endobronchial non-small cell lung cancer
Filed a supplemental new drug submission in Canada (7/7)
QLT PhotoTher- apeutics Inc. and Sanofi Pharma- ceuticals Inc.
Photofrin
Photosensitive drug (produces toxic oxygen compound when light- activated)
Treatment of early stage endobronchial non-small cell lung cancer in patients who are not indicated for surgery or radiotherapy
Cleared for marketing in Germany (8/7)
QLT PhotoTher- apeutics Inc. and Ligand Pharma- ceuticals Inc.
Photofrin
Photosensitive drug (produces toxic oxygen compound when light- activated) microtubules
Specific types of non- small cell lung cancer
QLT submitted application in Canada for approval of additional indication (8/6)
Rhone-Poulenc Rorer Inc. (subsidiary of Rhone-Poulenc Group; France)
Taxotere
Docetaxel; semisynthe- tic agent derived from needles of the European yew tree; inhibits cancer cell division by prevent- ing assembly and block- ing disassembly of microtubules
Treatment of advanced or metastatic breast can- cer (in both countries); also for treating advanced non-small cell lung can- cer (in Malaysia)
Approved for marketing in Malaysia and Hungary (4/10)
Rhone-Poulenc Rorer Inc. (subsidiary of Rhone-Poulenc Group; France)
Rilutek Tablets
Riluzole; benzothiazole compound that inhibits release of glutamate in central nervous system
Amyotrophic lateral sclerosis
Cleared for marketing in Columbia, Israel, Mexico, Peru and Uruguay (7/17)
Rhone-Poulenc Rorer Inc. (subsidiary of Rhone-Poulenc Group; France)
Granocyte (lenograstim)
Glycosylated recombi- nant human granulocyte colony-stimulating factor
Prevention of infection and reduction of neutropenia in chemotherapy patients
Cleared for marketing in Bulgaria, Chile, Cyprus, Colombia, Ecuador, Egypt, India, Indonesia, Israel, the Ivory Coast, Lebanon, the Philippines, the Slovak Republic and Uruguay (8/7)
Rhone-Poulenc Rorer Inc. (subsidiary of Rhone-Poulenc Group; France)
Taxotere
Docetaxel; semisyn- thetic agent derived from needles of the European yew tree; inhibits cancer cell division by prevent- ing assembly and blocking disassembly of microtubules
Treatment of advanced metastatic breast cancer and non-small cell lung cancer
Cleared for marketing in Belarus, Croatia, Indo- nesia and Kuwait (8/12)
Ribi ImmunoChem Research Inc.
Melacine
Therapeutic cancer vaccine made of lysed cells from 2 human melanoma cell lines with a broad array of mela- noma antigens, combined with Ribi¿s Detox adjuvant (contains monophosphoryl lipid A and mycobacterial cell-wall skeleton)
Stage IV melanoma for which there is no conventional therapy
New drug submission (which was filed 7/97) has cleared 45-day preliminary review by Canadian Health Protect- ion Branch, which accept- ed it for review on a fast- track basis (9/25)
SangStat Medical Corp. and Gensia Sicor Inc.
Cyclosporine
Immunosuppressive drug (generic formu- lation)
To prevent graft reject- ion in transplants
Received approval to manufacture cyclosporine bulk drug substance in the European Union (12/11)
Scotia Holdings plc (U.K.)
Tarabetic
Gamma-linolenic acid in the form of evening primrose oil
Diabetic neuropathy
Appeal of Medicines Control Agency¿s non- approval denied (12/22)
Sequus Pharmaceuticals Inc.
Amphocil (a.k.a. Amphotec)
Lipid-based colloidal dispersion of ampho- tericin B
Treatment of severe systemic fungal infect- ions and/or deep mycoses (2nd-line therapy)
Approved for marketing in Portugal (2/27)
Sequus Pharmaceuticals Inc. and Schering Plough Corp.
Caelyx (a.k.a. Doxil)
Doxorubucin HCl (pegylated liposomal)
Kaposi¿s sarcoma
Cleared for marketing in Australia and New Zealand (7/30)
Sonus Pharmaceuticals Inc.
EchoGen Emulsion
Fluorocarbon-based ultrasound contrast agent
To enhance diagnostic accuracy of ultrasound procedures in radiology and cardiology
European Medicines Evaluation Agency accep- ted Marketing Authoriza- tion Application for filing (1/8)
Teva Pharmaceutical Industries Ltd. (Israel)
Copaxone
Copolymer-1; four- amino acid peptide deived from myelin basic protein
Multiple sclerosis
Approved for marketing in Canada (9/4)
Unigene Laboratories Inc.
Fortical Injection
Recombinant salmon calcitonin
Osteoporosis
Product registration appli- cation submitted to Europe¿s Committee for Proprietary Medicinal Products, which also accepted the application for review (9/29)
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