Company

Product

Description

Indication

Type Action/Date

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Diaspirin cross-linked hemoglobin (purified from outdated human donor blood)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.)

Crinone

Vaginally delivered natural progesterone gel

Hormone replacement therapy, infertility treatment, premenstrual syndrome, secondary amenorrhea, dysmenorrhea and abnormal uterine bleeding

Cleared for marketing in Mexico (7/31)

Cor Therapeutics Inc.

Integrilin

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 1ream (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

Hoffmann-La Roche filed Marketing Authorization Application with Euro- pean Medicines Evalua- tion Agency (9/4)

QLT Photo- therapeutics Inc.

Photofrin (porfimer sodium)

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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