FDA PRODUCT APPROVALS IN 1990CompanyProductUseMonth approved

Abbott Laboratories/ChironHepatitis C virus diagnosticTest donor bloodJuly

Armour Pharmaceutical Co.Monoclate (Monoclonal antibody-purified Factor VIII)HemophiliaMay

Burroughs Wellcome Co.Exosurf (artificial lung surfactant)Infant respiratory distress syndromeAugust

Cambridge Biotech Corp.AIDS antibody diagnosticsScreen donor blood screeningApril, June

Enzon Inc.PEG-Adenosine deaminaseSevere combined immune deficiencyMarch

Genentech, Inc.Activase (tissue plasminogen activator)Pulmonary embolismJune

Genentech, Inc.Actimmune (recombinant gamma interferon)Chronic granulomatous diseaseDecember

Oclassen PharmaceuticalsCondylox (nucleoside analog)External gential wartsDecember

Ortho Diagnostic Systems (Johnson & Johnson)HCV Elisa Test SystemTest donor blood for Hepatitis CApril

Pfizer Inc.Recombinant renninCheese makingMarch

Praxis Biologics Inc. (American Cyanamid)Haemophilus influenza B/diphtheria conjugate vaccineVaccinate infants under 6 monthsOctober

Syngene Inc. (Molecular Biosystems Inc.)Synthetic Nucleic Acid Probe Mycobacterium DiagnosticsIn vitro test for mycobacteriaApril

OTHER PRODUCTS LAUNCHED IN 1990

California Biotechnology Inc.Recombinant feline leukemia virus vaccineProphylaxis (USDA)January

Cambridge Biotech Corp.Recombinant feline leukemia virus vaccineProphylaxis (USDA)October

Cetus Corp.Amplitype DNA amplification and typingDNA fingerprintingFebruary

Marrow-Tech Inc.In vitro artificial skin toxicity kitsAlternative to animal and cell culture testsNovember

Oncor Inc.DNA Probe Test SystemPrenatal detection of chromosomal abnormalitiesJanuary

T Cell SciencesCellfreer CD4 Test KitMeasures CD4 in the bloodFebruary

PRODUCT APPLICATIONS PENDING FDA REVIEW

Abbott LaboratoriesSurvanta (bovine surfactant extract). For treating infantrespiratory distress syndrome. A new drug application (NDA)was filed last March. Survanta received treatmentinvestigational new drug (IND) status in October 1989.

Amgen Inc.Neupogen (recombinant granulocyte colony-stimulating factor,G-CSF). An adjunct for cancer chemotherapy, it received abroad approval recommendation from an advisory panel onDec. 14.

Calgene Inc.Transgenic tomato, cotton and rapeseed containing a markergene. Company filed in November for evaluation of a markerfor antibiotic resistance in a food crop.

Centocor Inc.Centoxin (monoclonal antibody to endotoxin) for treating septicshock. An NDA was filed in September 1989.

Centocor Inc./Johnson & JohnsonMyoscint (monoclonal antibody to myosin) for in vivo detectionof cell damage associated with heart attack. Product approvalapplication was filed in March 1988.

Cetus Corp.Interleukin-2 to treat kidney cancer made a first pass in Julybefore an advisory panel, which requested additional data byDecember. An NDA was filed in December 1988.

Cytogen Corp.OncoScint OV103 to aid in detection of ovarian cancer.Application filed last April.

Genentech Inc./Cutter LabsFactor VIII for treating hemophilia. An NDA was filed inSeptember 1989.

Genetics Institute/Chugai-UpjohnErythropoietin (EPO) for treating dialysis-related anemia. AnNDA was filed in September 1988.

Genetics Institute/Schering-Plough/SandozLeukomax (recombinant GM-CSF) as an adjunct to AIDStherapy, bone marrow transplants and low white blood cellcount. An NDA was filed last February and it was the topic of aclosed-door session with an advisory panel in December.

Genetics Institute/BaxterFactor VIII for treating hemophilia. An NDA was filed last May.

Genzyme Corp.Ceredase (placental-derived human beta-glucocerebrosidase)for treating Gaucher's disease received an advisory panel'srecommendation for approval last October.

Hoechst-Roussel/Immunex Corp.Leukine (recombinant GM-CSF) for use in conjunction withbone marrow transplants received an advisory panel'sapproval recommendation on Dec. 13. It was granted treatmentIND status last September on a filing of last February.

Immunomedics Inc.Human anti-mouse antibody response diagnostic for testing anallergic response to mouse monoclonals. Application forapproval filed in December.

Johnson & Johnson/AmgenEprex (erythropoietin, or EPO) for treating anemia associatedwith AZT in treating AIDS. An advisory panel recommendedapproval last March.

Life Technologies Inc.Gene probe diagnostic for human papilloma virus received inDecember an advisory panel's recommendation for approval.

NeoRx Corp.OncoTrac small cell lung cancer imaging agent. An applicationwas filed in December 1989.

Schering Corp./BiogenIntron A (alpha interferon-2b) for treating hepatitis C receivedan advisory panel's recommendation for approval in July.

Schering Corp./BiogenIntron A (alpha interferon-2b) for treating hepatitis B anddelta. Application was filed in September 1989.

Schering Corp./BiogenIntron A (alpha interferon-2b) for treatment of basal cell andbladder cancers. Applications filed in December 1987 andDecember 1988.

Triton Bioscience (Berlex Bioscience)Fludara I.V. chemotherapeutic agent received in September anadvisory panel's recommendation for approval.

Xoma Corp.Xomen-E5 (Monoclonal antibody to endotoxin) to treat septicshockApplication filed in March 1989.

Xoma Corp.XomaZyme-CD5+ for treating graft-vs.-host disease. Applicationfiled in November 1988.

IN ADVANCED CLINICAL TRIALS

Alpha-1 Biomedicals Inc.Thymosin alpha-1 was approved for Phase III trials for chronichepatitis B.

Centocor Inc.Fibroscint (monoclonal antibody to fibrinogen) for in vivodetection of blood clots is expected to be filed for marketingapproval in early 1991.

Cytogen Corp.OncoRad (Ytrrium-90-labbeled monoclonal antibody) is inPhase II trials.

Epitope Inc.Saliva-based AIDS immunodiagnostic test is in Phase II testing.

Gensia Pharmaceuticals Inc.Arasine (acadesine) is in Phase II/III clinicals to reduce tissuedamage in coronary bypass patients.

Gensia Pharmaceuticals Inc.ESA System entered Phase II trials last summer, using thecontrolled delivery of arbutamine to aid in diagnosis ofcoronary artery disease.

HEM Research Inc.Ampligen (mismatched doubled-stranded RNA) entered inDecember Phase II/III for chronic fatigue syndrome.

Immune Response Corp.Killed HIV vaccine for AIDS is in Phase II/III trials in AIDSpatients.

Immunogen Inc.Oncolysin B (cancer-targeted monoclonal conjugated to blockedricin A chain) for treating B cell lymphomas and leukemias is inPhase II trials in non-Hodgkin's lymphoma patients.

Liposome CompanyTLC G-65 started in Phase II trials last November formycobacterium infections in AIDS patients.

Liposome CompanyAmphotericin B lipid complex entered Phase II trials to treatfungal infections of the brain in AIDS patients.

Liposome Technology Inc.Liposomal amphotericin B was approved in December for PhaseII studies in patients with disseminated fungal infections.

National Institutes of HealthWhite blood cells engineered with the gene for tumor necrosisfactor was granted final approval granted by the FDA for PhaseII testing.

NeoRx Corp.OncoTrac imaging kit is in Phase III trials to detect non-smallcell lung cancer.

ProCyte Corp.Iamin entered Phase II trials of wound-healing compound indiabetic patients.

Xoma Corp.XymaZyme-CD5 (immunoconjugate) entered Phase II trialswith rheumatoid arthritis patients.

NEW ENTRANTS TO CLINICALS IN 1990

Amgen Corp.G-CSF is in clinical tests for anti-infective activity.

Biogen Inc.Hirulog analog is in clinicals for thrombolytic activity.

Bio-Technology General Corp.Superoxide dismutase entered clinical tests in December withulcerative colitis patients.

Centocor Inc.Capiscint is in clinicals to image atherosclerotic plaques in vivo.

Centocor Inc.Ab-CD4 (murine and chimeric). The murine product enteredclinicals in arthritis patients.

Cetus Corp.T88 antibody entered clinicals to treat septic shock.

Chiron Corp.Anti-TNF antibody entered in clinicals to treat septic shock.

Chiron Corp.PDGF is in clinical tests to heal fullthickness wounds.

Cytogen Corp.Technetium-99-labeled monoclonal antibody fragment wasapproved for testing to diagnose breast and non-small cell lungcancer.

Cytogen Corp.Indium-111-labeled monoclonal antibody was approved fortesting in diagnosing colorectal cancer.

Genentech Inc.The gp120 vaccine entered Phase I trials in November in AIDSpatients.

Genentech Inc.Relaxin began clinicals in February to ease difficult childbirth.

Genentech Inc.DNAse (DNA-cleaving enzyme) was announced in July to startPhase I trials in cystic fibrosis patients.

Genzyme Corp.Surgicoat (Hyaluronic acid) is in Phase I/II studies to testinhibition of adhesion formation.

Immunogen Inc.Oncolysin I (cancer-targeted monoclonal conjugated to blockedricin A chain) started clinicals in October for small cell lungcancer.

Immunomedics Inc.ImmuRAIT-LL2 immunoconjugate was approved in Decemberto start Phase I/II trials to treat B cell lymphomas.

Immunomedics Inc.ImmuRAID-MN3 immunoconjugate was approved in Decemberto start Phase I/II trials to detect inflammation and infections.

Immuno-U.S. Inc.The gp160 AIDS vaccine was approved in November for PhaseI trials.

Marrow-Tech Inc.DermaGraft dermal replacement received approval in Octoberto begin clinicals in burn patients.

MicroGeneSys Inc.The p24 AIDS vaccine is in Phase I trials.

Muscular Dystrophy AssociationHealthy muscle cells entered Phase II trials in June to improvemuscle function in patients with muscular dystrophy.

Seragen Inc.Interleukin-2/diphtheria toxin fusion protein completed PhaseI trials.

Synergen Inc.Interleukin-1 receptor antagonist entered in September PhaseI trials in rheumatoid arthritis patients.

Telios PharmaceuticalsTelio-Derm wound-healing peptide started Phase I trials inpatients following skin cancer surgery and skin grafts.

Viral Technologies Inc.HGP-30 AIDS vaccine was approved by California officials forPhase I trials in healthy volunteers.

(c) 1997 American Health Consultants. All rights reserved.

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