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
L-5-hydroxytryptophan Tetrahydrobiopterin deficiency Watson Laboratories, Inc.;311 Bonnie Circle, P.O. Box 1900;Corona, California, 91718 January 20, 1999
Interferon beta-1a (recombinant human) Pulmonary fibrosis Biogen Idec, Inc.;14 Cambridge Center;Cambridge, Massachusetts, 02142 January 7, 1999
Papain, trypsin, and chymotrypsin Multiple myeloma Marlyn Nutraceuticals, Inc.;14851 N. Scottsdale Rd.;Scottsdale, Arizona, 85254 December 21, 1998
Polyethylene glycol-modified uricase Tumor lysis syndrome in cancer patients undergoing chemotherapy EnzymeRx, LLC;17 Arcadian Avenue, Suite 104;Paramus, New Jersey, 07652 December 21, 1998
Deferoxamine starch conjugate Beta-thalassemia Biomedical Frontiers, Inc.;108710th Ave., S.E.;Minneapolis, Minnesota, 55414 December 21, 1998
Follitropin alfa, recombinant For the initiation and re-initiation of spermatogenesis in adult males with reproductive failure due to hypothalamic or pituitary dysfunction, hypogonadotropic hypogonadism. AMENDED indication 6/27/00: For the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure. EMD Serono, Inc.;One Technology Place;Rockland, Massachusetts, 02370 December 21, 1998
Murine MAb (Lym-1) and Iodine 131-I radiolabeled murine MAb (Lym-1) to human B-cell lymphoma B-cell non-Hodgkin's lymphoma Peregrine Pharmaceuticals, Inc.;14272 Franklin Ave., Suite 100;Tustin, California, 92780 November 27, 1998
Xenogeneic hepatocytes Severe liver failure Circe Biomedical, Inc.;99 Hayden Ave.;Lexington, Massachusetts, 02421 November 27, 1998
Aldesleukin For the treatment non-Hodgkin's lymphoma Prometheus Laboratories, Inc.;9410 Carroll Park Drive;San Diego, California, 92121 November 24, 1998
Amifostine For the reduction of the incidence and severity of toxicities associated with cisplatin administration Clinigen Group plc;Pitcairn House, Crown Square, DE14 2WW; November 24, 1998
MN14 monoclonal antibody to carcinoembryonic antigen Pancreatic cancer Immunomedics, Inc.;300 The American Road;Morris Plains, New Jersey, 07950 November 24, 1998
Humanized anti-CD2 monoclonal antibody Graft Versus Host Disease MedImmune, Inc.;35 West Watkins Mill Rd.;Gaithersburg, Maryland, 20878 November 13, 1998
Oxypurinol Hyperuricemia in patients intolerant to allopurinol Cardiome Pharma Corp.;3650 Westbrook Mall, Vancouver, B.C.; November 9, 1998
Doxorubicin liposome Ovarian cancer Alza Corporation;1550 Plymouth St., PO Box 7210;Mountain View, California, 94039 November 4, 1998
Etanercept Reduction in signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs Immunex Corporation;One Amgen Center Drive;Thousand Oaks, California, 91320 October 27, 1998
P1, P4-Di(uridine 5′-tetraphosphate), tetrasodium salt Cystic fibrosis Inspire Pharmaceuticals, Inc.;4222 Emperor Blvd., Suite 470;Durham, North Carolina, 27703 October 27, 1998
Temozolomide Advanced metastatic melanoma Merck & Company;2000 Galloping Hill Rd.;Kenilworth, New Jersey, 07033 October 14, 1998
Methoxsalen For use in conjunction with the UVAR photopheresis system to treat graft versus host disease Therakos, Inc.;1001 Route 202;Raritan, New Jersey, 08869 October 14, 1998
Mecamylamine Tourette syndrome Targacept, Inc.;200 East First St., Suite 300;Winston-Salem, North Carolina, 27101 October 14, 1998
Thalidomide Multiple myeloma Celgene Corporation;7 Powder Horn Dr.;Warren October 14, 1998
Recombinant humanized MAb 5c8 Hemophilia A Biogen, Inc.;14 Cambridge Center;Cambridge, Massachusetts, 02142 October 14, 1998
MN14 monoclonal antibody to carcinoembryonic antigen Small cell lung cancer Immunomedics, Inc.;300 The American Road;Morris Plains, New Jersey, 07950 September 18, 1998
Humanized anti-human CD2 MAb For the induction of donor-specific immunologic unresponsiveness resulting in prophylaxis of organ rejection without the need for chronic immunosuppressive therapy, in patients receiving allogeneic renal transplants Biotransplant, Inc.;Building 75, 3rd. Ave., Charlestown Navy Yard;Charlestown, Massachusetts, 02129 September 17, 1998
3-(3,5-dimethyl-1H-2ylmethylene)-1,3-dihydro-indol-2-one Kaposi sarcoma Sugen, Inc.;230 East Grand Ave.;South San Francisco, California, 94080 September 11, 1998
Dexamethasone intravitreal implant Panuveitis Allergan;2525 Dupont Drive;Irvine, California, 92623 September 11, 1998