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Orphan Drug Designations and Approvals List as of 12‐01‐2014
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Document Date: 2015-01-09 02:11:43

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File Size: 1,74 MB

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Company

L. Laboratories Inc. / 309 Designation Contact Company/Sponsor Bayer Corporation / 5Immunex Corporation / 309 Glaxo Wellcome Inc. / Roberts Pharmaceutical Corp. / Ethitek Pharmaceuticals Inc. / DuPont Pharmaceuticals / Jazz Pharmaceuticals / 309 Contact Company/Sponsor Ferring Laboratories Inc. / Contact Company/Sponsor Medimmune Oncology Inc. / Contact Company/Sponsor Pharmacia-Chiron Partnership / Degussa Corporation / Procter & Gamble / Ross Laboratories / Wilson / Sharp & Dohme Research CSL Behring LLC / Merck / Genentech Inc. / Du Pont / Aventis Behring L.L.C. / Abbott Laboratories / 309 Allergan Inc. / MGI Pharma Inc. / Amgen Inc. / Alza Corporation Trade / Bristol-Myers Squibb Company / Suspension 61 Beractant Survanta Intratracheal Suspension Contact Company / 309 Designation Lederle Laboratories Lemmon Company Genentech Inc. / Sigma-Tau Pharmaceuticals Inc. / ONY Inc. / 309 Genzyme Corporation / Hoechst Marion Roussel Glaxo Wellcome Inc. / Biodevelopment Corporation Pharmacia & Upjohn AB / DCT Rhone-Poulenc Rorer Pharmaceuticals Inc. / gram- Centocor Inc. / M.D. Medimmune Oncology Inc. / Fisons Corporation / Myers Squibb Pharmaceutical Research Institute Somerset Pharmaceuticals Inc. / Mannheim Corp. / Glaxo Wellcome Inc. / Elkins-Sinn Inc. / Pneumocystis Fujisawa USA Inc. / M.D. Solvay Watson Laboratories Inc. / Bayer Corporation / Research Institute Somerset Pharmaceuticals / Inc. / /

Event

FDA Phase / /

Facility

University of Texas Health Science Center / National Cancer Institute / Dallas University of Texas Health Science Center / /

IndustryTerm

prevention of ONY / Inc. respiratory failure / adrenal cortical imaging / Treatment of thrombocytosis in chronic myelogenous leukemia / Prevention of neonatal respiratory distress syndrome / Treatment of refractory childhood acute lymphocytic leukemia / treatment of children who have growth failure / ophthalmic solution / treatment of metastatic colorectal cancer / Treatment of patients with Wilson's disease / Treatment of neonatal respiratory distress syndrome / Treatment of Wilson's disease / treatment of idiopathic Parkinson's disease / Treatment of AIDS / Treatment of acute lymphocytic Jazz Pharmaceuticals / leukemia / /

MedicalCondition

thrombocytosis / hypocalcemia / hereditary coproporphyria / argininosuccinate synthetase deficiency / Gaucher's disease type I. For blockade / uric acid nephrolithiasis / thrombotic thrombocytopenic purpura / interstitial cystitis / systemic disease / ifosfamide-induced hemorrhagic cystitis / injury / cholesterol gallstones / lead poisoning / lepromatous leprosy / advanced adenocarcinoma / homozygous cystinuria / cervical dystonia / endotoxin shock / acute lymphocytic leukemia / symptomatic Parkinsonism / postanoxic intention myoclonus / postencephalitic Parkinsonism / primary pulmonary hypertension / Pneumocystis carinii pneumonia / neonatal respiratory distress syndrome / thromboembolism / pulmonary surfactant deficiency / either hypoparathyroidism / primary and secondary carnitine deficiency / inhibitor congenital deficiency / mucous deficiency / chronic myelogenous leukemia / pulmonary emboli / hereditary antithrombin III / AIDS / deficiency / symptomatic orthostatic hypotension / vernal keratoconjunctivitis / polycythemia vera / nephropathic cystinosis / cystine nephrolithiasis / erythema nodosum leprosum / soft tissue sarcomas / Turner's syndrome / intermittent porphyria / hemiplegia / osteogenic sarcoma / Wilson's disease / Inc. with severe combined immunodeficiency / genetic carnitine deficiency / porphyria / hyperkalemia / conduction disorders / dapsoneresistant lepromatous leprosy / paralysis agitans / stage renal disease / metastatic colorectal cancer / Trypanosoma brucei gambiense infection / sickness / ATIII deficiency / congenital deficiency / pseudohypoparathyroidism / pain / hypercalcemia / mastocytosis / idiopathic Parkinson's disease / strabismus / esophageal varices / thrombosis / anemia / tuberculosis / /

MedicalTreatment

leukapheresis / surgery / adjunctive therapy / incisions / elective surgery / corneal transplant surgery / enzyme replacement therapy / /

Organization

University of Texas Health Science Center at Dallas / Red Cross / National Cancer Institute / Dallas University of Texas Health Science Center / /

Person

David E. Kuhl / /

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Product

Pentam / Leucovorin Calcium / Sanorex / Flolan / Retrovir / Didronel / Elmiron / Etidronate disodium / Tretinoin / Methotrexate sodium / Lamprene / Galzin / Mesnex / Ornidyl / Bacitracin / pyrazinamide / Sotradecol / Eldepryl / Hexalen / Moctanin / Digoxin / Potassium citrate / Survanta / Ethamolin / Ceredase / Alglucerase injection / Chlorhexidine gluconate / Ifex / Intratracheal Suspension / Carnitor / Numorphan / Syprine / Chenix / Adagen / Vumon / Mesna / Zidovudine / Urocit-K / Humatrope / Chemet / Neutrexin / Cromolyn sodium / Tiopronin / Pentamidine isethionate / Ifosfamide / Rifadin / Parathar / Opticrom / isoniazid / Rifampin / Gastrocrom / Rifater / Levocarnitine / Hoechst Marion Roussel / For Injection / Peridex / Orlaam / Protropin / Agrylin / fluorouracil / Ucephan / E. Kuhl / Merck / /

Technology

alpha / transplantation / /

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