Treatments

The following database contains products that have been granted orphan status, or have been market approval in the EU or the USA.

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Country Product Indication Sponsor Date
Interleukin-1 receptor antagonist, human recombinant Juvenile rheumatoid arthritis Swedish Orphan Biovitrum AB (publ) (SOBI);SE-112 76;Stockholm September 23, 1991
Exemestane Advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy Pharmacia & Upjohn;7000 Portage Road, Mail Stop: 0636-298-113;Kalamazoo, Michigan, 49001 September 19, 1991
Toremifene Hormonal therapy of metastatic carcinoma of the breast Orion Corporation;Orionintie 1, 0FI-02200 ESPOO; September 19, 1991
Monoclonal antibody to cytomegalovirus (human) Prophylaxis of cytomegalovirus disease in patients undergoing solid organ transplantation Protein Design Labs, Inc.;2375 Garcia Avenue;Mountain View, California, 94043 September 13, 1991
Oxandrolone Adjunctive therapy for AIDS patients suffering from HIV-wasting syndrome Bio-Technology General Corp.;70 Wood Avenue South;Iselin, New Jersey, 08830 September 6, 1991
Filgrastim Patients with AIDS who, in addition, are afflicted with cytomegalovirus retinitis and are being treated with ganciclovir Amgen, Inc.;One Amgen Center Dr.;Thousand Oaks, California, 91320 September 3, 1991
Atovaquone Prevention of Pneumocystis carinii pneumonia (PCP) in high-risk, HIV-infected patients defined by a history of one or more episodes of PCP and/or a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm3 Glaxo Wellcome Research and Development;5 Moore Drive, PO Box 13398;Research Triangle Park, North Carolina, 27709 August 14, 1991
Tiratricol For use in combination with levo-thyroxine to suppress thyroid stimulating hormone in patients with well-differentiated thyroid cancer who are intolerant to adequate doses of levo-thyroxine alone Laphal Laboratoires;48 Bis, Rue des Belles-Feuilles, 75116 Paris; August 13, 1991
Mecasermin Amyotrophic lateral sclerosis Teva Branded Pharmaceutical Products R&D;, Inc.;41 Moores Road;Frazer, Pennsylvania, 19355 August 5, 1991
Cyclosporine 2% ophthalmic ointment For use in corneal melting syndromes of known or presumed immunologic etiopathogenesis, including Mooren's ulcer Allergan, Inc.;2525 Dupont Drive, P. O. Box 19534;Irvine, California, 92612 August 1, 1991
Levoleucovorin For use in conjunction with high-dose methotrexate in the treatment of osteosarcoma Spectrum Pharmaceuticals, Inc.;157 Technology Drive;Irvine, California, 92618 August 1, 1991
Cyclosporine 2% ophthalmic ointment Patients at high risk of graft rejection following penetrating keratoplasty Allergan, Inc.;2525 Dupont Drive, P. O. Box 19534;Irvine, California, 92612 August 1, 1991
Testosterone propionate ointment 2% Vulvar dystrophies Star Pharmaceuticals, Inc.;1990 N.W. 44th Street;Pompano Beach, Florida, 33064 July 31, 1991
Epoetin alfa Anemia associated with HIV infection or HIV treatment Amgen, Inc.;1840 Dehavilland Drive;Thousand Oaks, California, 91320 July 1, 1991
Monoclonal antibody PM-81 Adjunctive treatment of acute myelogenous leukemia Medarex, Inc.;519 Route 173 West;Bloomsbury, New Jersey, 08804 June 27, 1991
Myelin Multiple sclerosis AutoImmune, Inc.;128 Spring Street;Lexington, Massachusetts, 02173 June 27, 1991
Ursodiol Primary biliary cirrhosis Aptalis Pharma US, Inc.;100 Somerset corporate Blvd;Bridgewater, New Jersey, 08807 June 20, 1991
Alpha-galactosidase A Fabry disease David Calhoun, Ph.D.;Department of Chemistry, Convent Avenue & 138th Street;New York, New York, 10031 June 17, 1991
Monoclonal antibody to hepatitis B virus (human) Prophylaxis of hepatitis B reinfection in patients undergoing liver transplantation secondary to end-stage chronic hepatitis B infection Protein Design Labs, Inc.;34801 Campus Dr.;Fremont, California, 94555 June 17, 1991
Interleukin-1 alpha, human recombinant For the promotion of early engraftment in bone marrow transplantation Immunex Corporation;51 University Street;Seattle, Washington, 98101 June 17, 1991
Interleukin-1 alpha, human recombinant For hematopoietic potentiation in aplastic anemia Immunex Corporation;51 University Street;Seattle, Washington, 98101 June 17, 1991
Nifedipine Interstitial cystitis Fleischmann, Jonathan M.D.;MetroHealth Medical Center, 3395 Scranton Road;Cleveland, Ohio, 44109 June 13, 1991
Chimeric M-T412 (human-murine) IgG monoclonal anti-CD4 Multiple sclerosis Centocor, Inc.;244 Great Valley Parkway;Malvern, Pennsylvania, 19355 June 5, 1991
Fosphenytoin Status epilepticus Warner-Lambert Company;2800 Plymouth Road;Ann Arbor, Michigan, 48106 June 4, 1991
Calcium gluconate gel For use in the emergency topical treatment of hydrogen fluoride (hydrofluoric acid) burns Calgonate Corporation;3310 South Ocean Blvd, Unit 132;Highland Beach, Florida, 33487 May 21, 1991