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1、Orphan Products Designations and Approvals ListThroughFebruary 2001Name:Sponsor & AddressGeneric NameDD=Date DesignatedTN=Trade NameIndication Designated:MA=Marketing Approval1,5-(Butylimino)-1,5 Treatment of Fabrys disease.Oxford GlycoSciencesdideoxy,D-glucitol10, The QuadrantTN=Abington Science Pa
2、rk, AbingtonOxfordshire OX14 3YS UK DD=5/12/98MA=1,5-(Butylimino)-1,5 Treatment of Gaucher disease.Oxford GlycoSciencesdideoxy,D-glucitol10, The QuadrantTN=Abington Science Park, AbingtonOxfordshire OX14 3YS UK DD=5/29/98MA=1-(11-dodecylamino-10-hyTreatment of hormone refractory Cell Therapeutics, I
3、nc.droxyundecyl)-3,7-dimethprostate carcinoma.201 Elliott Avenue WestTN=Suite 400Seattle WA 98119 DD=1/18/00MA=111Indium pentetreotideTreatment of somatostatin receptor Louisiana State University positive neuroendocrine tumors.1600 Canal St.TN=SomatoTher10th FloorNew Orleans LA 70112 DD=6/10/99MA=15
4、AU81Treatment of pulmonary arterial United Therapeutics Corp.hypertension.68 T.W. Alexander Dr.TN=P.O. Box 14186Research Triangle Park NC 27709DD=6/4/97MA=Name:Sponsor & AddressGeneric NameDD=Date DesignatedTN=Trade NameIndication Designated:MA=Marketing Approval166Ho-DOTMPTreatment of multiple myel
5、oma.NeoRx Corporation410 W. Harrison StreetTN=Seattle WA 98119-4007 DD=2/10/99MA=2-3-dideoxyadenosineTreatment of aquired National Cancer Institute, Dctimmunodeficiency syndrome.NIH, Exec. Plaza N., Room 7-18TN=Bethesda MD 20892 DD=7/21/87MA=2-deoxycytidineAs a host-protective agent in the Grant, St
6、even M.D.treatment of acute myelogenous Massey Cancer Center, VCUTN=leukemia.P.O. Box 980230Richmond VA 23298-0230DD=9/9/96MA=2-0-desulfated heparinTreatment of cystic fibrosis.Kennedy & Hoidal, M.D.sUniversity of Utah Health TN=Aeropin50 North Medical Drive, Room Salt Lake City UT 84132 DD=9/17/93M
7、A=24,25 Treatment of uremic osteodystrophy.Lemmon Companydihydroxycholecalciferol1510 Delp DriveTN=Kulpsville PA 19443 DD=2/27/87MA=3-azido-2,3dideoxyuriTreatment of acquired Berlex Laboratories, Inc.dineimmunodeficiency syndrome.1401 Harbor Bay ParkwayTN=AZDUAlameda CA 94501 DD=11/20/89MA=Name:Spon
8、sor & AddressGeneric NameDD=Date DesignatedTN=Trade NameIndication Designated:MA=Marketing Approval3,4-diaminopyridineTreatment of Lambert-Eaton Jacobus Pharmaceutical Companymyasthenic syndrome.37 Cleveland AvenueTN=P.O. Box 5290Princeton NJ 08540 DD=12/18/90MA=3,5,3-triiodothyroacetaTreatment of w
9、ell-differentiated Elliot Danforth, Jr., M.D.tepapillary, follicular or combined University of VermontTN=papillary/follicular carcinomas of 84 Beartown Roadthe thyroid gland.Underhill VT 05489 DD=9/20/99MA=3-(3,5-Dimethyl-1H-2ylmeTreatment of von Hippel-Lindau Sugen, Inc.thylene)-1,3-dihydro-inddise
10、ase.230 East Grand Ave.TN=South San Francisco CA 94080 DD=3/23/00MA=3-(3,5-dimethyl-1H-2ylmeTreatment of Kaposis sarcoma. Sugen, Inc.thylene)-1,3-dihydro-ind230 East Grand Ave.TN=South San Francisco CA DD=9/11/98MA=4-aminosalicylic acidTreatment of mild to moderate Beeken, Warren M.D.ulcerative coli
11、tis in patients University Of VermontTN=Pamisyl (P-D), intolerant to sulfasalazine.Given C-317Burlington VT 05405 DD=12/13/89MA=40SD02Treatment of chronic iron overload Biomedical Frontiers, Inc.resulting from conventional 1095 10th Ave., S.E.TN=transfusional treatment of Minneapolis MN 55414 beta-t
12、halassemia major and sickle cell anemia. DD=12/21/98MA=Name:Sponsor & AddressGeneric NameDD=Date DesignatedTN=Trade NameIndication Designated:MA=Marketing Approval5,6-dihydro-5-azacytidinTreatment of malignant ILEX Oncology, Inc.emesothelioma.4545 Horizon Hill Blvd.TN=San Antonio TX 78229-2263 DD=5/
13、11/92MA=5-aza-2-deoxycytidineTreatment of acute leukemia.Pharmachemie U.S.A., Inc.1510 Delp Dr.TN=Kulpsville PA 19443 DD=8/3/87MA=506U78Treatment of chronic lymphocytic Glaxo Wellcome, Inc.leukemia.Five Moore Dr.TN=P.O. Box 13398Research Triangle Park NC DD=9/2/99MA=5a8, monoclonal antibodyFor use i
14、n post-exposure Biogen, Inc. to CD4prophylaxis for occupational 14 Cambridge CenterTN=exposure to human immunodeficiency Cambridge MA 02142 virus. DD=12/20/93MA=6-hydroxymethylacylfulveTreatment of histologically MGI Pharma, Inc.neconfirmed advanced or metastatic 6300 West Old Shakoppe Rd.TN=pancreatic cancer.Suite 110Bloomington MN 55438-2318DD=4/6/99MA=6-hydroxymethylacylfulveTreatment of renal cell carcinoma.MGI Pharma, Inc.ne6300 West Old Shakoppe Rd.TN=Suite 110Bloomington MN 55438
