European Medicines Evaluation Agency said it has deferred decision on marketing authorization application until the results of an ongoing 2nd pivotal trial are available (necessary to provide definitive proof of efficacy) (2/5)
Centocor Inc.
Infliximab (formerly Avakine)
Chimeric monoclonal antibody to tumor necrosis factor-alpha
Moderate-to-severe Crohn¿s disease, including fistulizing Crohn¿s disease
Submitted marketing authorization application to European Agency for Evaluation of Medicinal Products (3/6)
Cephalon Inc.
Provigil
Modafinil; oral formulation of synthetic compound that is thought to affect alpha-adrenergic receptors in the brain
Narcolepsy (sleep disorder)
Approved for marketing in Republic of Ireland (5/15)
Cephalon Inc. and Chiron Corp.
Myotrophin
Mecasermin; recombinant human insulin-like growth factor (injection)
Amyotrophic lateral sclerosis
Companies withdrew application to market product in Europe (9/15)
Chiron Corp. and Hyup Jin Corp. (South Korea)
Proleukin
Aldesleukin; recombinant human interleukin-2
Metastatic renal cell carcinoma
Approved for marketing in South Korea (8/12)
Chiroscience Group
Chirocaine (levobupivacaine)
Long-acting local anesthetic
Alleviation of acute and chronic pain in adults and children
Approved for marketing in Sweden (12/16)
CollaGenex Pharmaceuticals Inc.
Periostat
Orally administered drug consisting of subantibiotic dose of doxycycline (inhibits production of collagenase)
Adjunct to scaling and root planing for treating moderate to severe periodontitis in adults
Submitted marketing authorization application with U.K.¿s Medicines Control Agency (10/28)
1st-line therapy in severe confirmed systemic fungal infections; empirical treatment of fungal infections in severely neutropenic patients; treatment of visceral leishmaniasis in immunocompormised patients
Broad expansion of label approved in Spain (6/11)
NeXstar Pharmaceuticals Inc.
AmBisome
Liposomal formulation of amphotericin B
2nd-line therapy for systemic fungal infections and for visceral leishmaniasis
Approved for marketing in France (6/10)
NeXstar Pharmaceuticals Inc.
AmBisome
Liposomal formulation of amphotericin B
Empirical treatment of presumed fungal infections in febrile neutropenic patients
U.K.¿s Medicines Control Agency approved expanded label (new indication) (8/18)
North American Vaccine Inc.
DTaP-IPV Vaccine
Combines Certiva, a DTP vaccine, with injectable inactivated polio vaccine
Vaccination for pertussis, diphtheria, tetanus and polio in infants and children
Completed registration process for marketing authorization in Austria, Germany, Sweden and Finland (6/11)
Noven Pharmaceuticals Inc.
____
2nd-generation transdermal estrogen system (transdermal 17-beta estradiol)
Menopausal symptoms
Submitted marketing authorization application in U.K. (7/1)
Novopharm Biotech Inc. (TSE:NVO; Canada)
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Generic paclitaxel
Breast and ovarian cancer
Submitted ANDA in Canada (9/10)
PathoGenesis Corp.
TOBI
Tobramycin for inhalation
Chronic lung infections (Pseudomonas aeruginosa) in patients with cystic fibrosis
Filed new drug submission in Canada; product granted priority review status (3/23)
Protein Design Labs Inc. and F. Hoffmann-La Roche AG (Switzerland)
Zenapax
Daclizumab; humanized monoclonal antibody (SMART Anti-TAC) that binds to the interleukin-2 receptor on activated T cells
Combination therapy with other anti-rejection drugs (cyclosporine and corticosteroids) for reducing incidence of acute rejection episodes in liver transplantation
Approved for marketing in Switzerland (3/3)
Protein Design Labs Inc. and Hoffmann-La Roche Inc.
Zenapax
Daclizumab; humanized monoclonal antibody (SMART Anti-TAC) that binds to the interleukin-2 receptor on activated T cells
Prevention of acute organ rejection in kidney transplant patients
Committee For Proprietary Medicinal Products recommended approval in European Union (11/30)
QLT PhotoTherapeutics Inc. (Canada) and Beaufour Ipsen Group (France)
Photofrin
Photosensitive drug (produces toxic oxygen compound when light-activated)
Treatment of superficial endobronchial non-small-cell lung cancer in patients not indicated for surgery or radiation; palliative treatment of obstructing non-small-cell lung cancer; and palliative treatment of obstructing esophageal cancer
Submitted Marketing Authorization Applications in the U.K., Ireland, Spain, Portugal, Belgium, Denmark, Sweden, Finland and Greece (1/6)
Rhone-Poulenc Rorer Inc. (subsidiary of Rhone-Poulenc SA; NYSE:RP; France)
Taxotere
Docetaxel; semisynthetic agent derived from needles of the European yew tree; inhibits cancer cell division by preventing assembly and blocking disassembly of microtubules
Treatment of advanced metastatic breast cancer and non-small-cell lung cancer
Approved for marketing in People¿s Republic of China (2/26)
Rhone-Poulenc Rorer Inc. (subsidiary of Rhone-Poulenc SA; NYSE:RP; France)
Granocyte
Lenograstim; glycosylated recombinant human granulocyte colony-stimulating factor
Prevention of infection and reduction of neutropenia in chemotherapy patients
Approved for marketing in Algeria, Cameroon, Kazakhstan, Malaysia, Poland, Romania and Slovenia (3/9)
Rhone-Poulenc Rorer Inc. (subsidiary of Rhone-Poulenc SA; NYSE:RP; France)
Taxotere
Docetaxel; semisynthetic agent derived from needles of the European yew tree; inhibits cancer cell division by preventing assembly and blocking disassembly of microtubules
Treatment of advanced metastatic breast cancer
Approved for marketing in Algeria, Bahrain, Bangladesh, Cameroon, Guatemala, Iran, Ivory Coast, Kenya, Lebanon, Slovenia and Thailand (3/9)
Rhone-Poulenc Rorer Inc. (subsidiary of Rhone-Poulenc SA; NYSE:RP; France)
Taxotere
Docetaxel; semisynthetic agent derived from needles of the European yew tree; inhibits cancer cell division by preventing assembly and blocking disassembly of microtubules
Treatment of non-small cell lung cancer
Approved for marketing in Algeria, Guatemala, Iran, Kenya, Slovenia, South Korea and Thailand (3/9)
Ribi ImmunoChem Research Inc.
Melacine
Therapeutic cancer vaccine made of lysed cells from 2 human melanoma cell lines with a broad array of melanoma antigens, combined with Detox adjuvant
Stage IV melanoma
Company withdrew European marketing application, after European Agency For Evaluation of Medicinal Products said that company would have to conduct additional Phase III studies before it would continue review of application (11/2)
SangStat Medical Corp.
Cyclosporine
Cyclosporine generic drug (immunosuppressive)
Prevention of graft rejection in organ transplantation
Submitted marketing authorization application in Europe (2/12)
SciClone Pharmaceuticals Inc.
Zadaxin (thymosin alpha 1)
Synthetic version of naturally occurring peptide hormone thymosin (immunomodulator)
Hepatitis B virus infection;
Approved for marketing in Peru (2/25), Kuwait (3/24); Myanmar (formerly Burma) (8/27); Cambodia (12/16)
SciClone Pharmaceuticals Inc.
Zadaxin (thymosin alpha 1)
Synthetic version of naturally occurring peptide hormone thymosin (immunomodulator)
Influenza vaccine adjuvant
Approved for marketing in Argentina (2/25) and Mexico (12/16)
SciClone Pharmaceuticals Inc.
Zadaxin (thymosin alpha 1)
Synthetic version of naturally occurring peptide hormone thymosin (immunomodulator)
Chronic hepatitis C virus infection
Approved for marketing in the Philippines (8/27) and Cambodia (12/16)
SciClone Pharmaceuticals Inc.
Zadaxin (thymosin alpha 1)
Synthetic version of naturally occurring peptide hormone thymosin (immunomodulator)
Chronic hepatitis B virus infection
Filed marketing applications in Laos and Taiwan (8/27)
Scotia Holdings plc (Scotland)
Amelorad
Combination of gamma linolenic acid and eicosapentaenoic acid
Reduction of radiation therapy-induced side effects in breast cancer patients
After European Medicines Evaluation Agency said that additional clinical trials were necessary to prove clinical benefit, company withdrew product license application (2/24)
Sonus Pharmaceuticals Inc. and Abbott Laboratories (NYSE:ABT)
EchoGen Emulsion
Fluorocarbon-based ultrasound contrast agent
Contrast radiography in patients with suspected or established cardiovascular disease
Committee for Propritary Medicinal Products recommended approval in European Union (3/30)
Theratechnologies Inc. (MSE:TH; Canada)
TH 9402
Photodynamic ex vivo purging process; bone marrow or peripheral blood withdrawn from patient, saturated with photosensitive molecule TH 9402 and purged by exposing to activated light; cells reinfused into patient
To restore bone marrow function in patients with chronic myeloid leukemia
Filed IND in Canada (1/6)
Unigene Laboratories Inc.
Fortical Injection
Recombinant salmon calcitonin
Paget¿s disease and hypercalcemia associated with cancer
European Committee for Proprietary Medicinal Products unanimously recommended approval (9/29)
Vertex Pharmaceuticals Inc. and Glaxo Wellcome plc (NYSE:GLX; U.K.)
Agenerase
Amprenavir; 2nd-generation HIV protease inhibitor; twice-daily dosage
Combination therapy with Retrovir (AZT) and Epivir (3TC) for HIV infection and AIDS in adults and children
Glaxo submitted application for marketing approval in Canada (10/20) and the European Union (11/2)
Vysis Inc.
AneuVysion EC Assay
Assay that uses fluorescence in situ hybridization (FISH) technology to measure aneuploid nuclei in amniocentesis specimens; 24-hour turnaround time
Prenatal genetic test for Down¿s syndrome and other chromosomal disorders associated with mental retardation and birth defects
Approved for marketing in France and throughout Europe (registered with Agence du Medicament) (3/24)
Vysis Inc.
PathVysion HER2 DNA Probe Kit
Assay based on fluorescent in situ hybridization technology (FISH); uses locus-specific, direct-label DNA probe that binds to HER2 gene in tissue biopsy
To detect and quantify HER2 gene in patients with breast cancer
Submitted marketing application in France (9/10)
Zonagen Inc. and Schering-Plough Corp. (NYSE:SGP)
Vasomax
Immediate-release oral formulation of phentolamine mesylate
Male erectile dysfunction
Schering-Plough filed product registration application in Mexico (3/19)
Zonagen Inc. and Schering-Plough Corp. (NYSE:SGP)
Z-MAX (a.k.a. Vasomax)
Immediate-release oral formulation of phentolamine mesylate
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