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Designated Indication Cumulative List of All Products That Have Received

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Designated Indication Cumulative List of All Products That Have Received Cumulative List of all Products that have received Orphan Designation: Total active designations: 2002 Effecive: 5/5/2009 Generic Name Trade Name Designated Indication treatmentMarketing and/or Approved modification Indication of the Designated Date Market Exculsivity Date following conditions, which are Vaccinia Immune Globulin complications resulting from smallpox (Human) Intravenous CNJ-016 ForTreatment the control of complications and prevention of vacciniaof hemorrhagic vaccination episodes vaccination: Eczema vaccinatum 18.06.2004 01.05.9999 and for surgical prophylaxis in patients with hemophilia Antihemophilic factor A (congenital factor VIII deficiency or classic (recombinant) ReFacto hemophilia). 08.02.1996 01.01.9999 For use as a thyroid blocking agent in For use as a thyroid blocking agent in pediatric patients pediatric patients exposed to Potassium Iodide Oral Solution ThyroShield exposed to radiactive iodine radiactive iodine 17.11.2004 01.01.9999 Treatment (rescue) of respiratory Pulmonary surfactant For the treatment and prevention of respiratory distress distress syndrome in premature replacement, porcine Curosurf syndrome in premature infants. Longinfants. term treatment of children with 02.08.1993 01.01.9999 growth failure due to inadequate Treatment of idiopathic or organic growth hormone secretion of endogenous growth Somatropin (rDNA origin) Saizen deficiency in children with growth failure. Long-termhormone. treatment of growth failure 06.03.1987 01.01.9999 Long-term treatment of children who have growth failure due to a lack of adequate endogenous due to a lack of adequate endogenous growth hormone growth hormone secetion for once- or Somatropin (rDNA origin) Nutropin Depot secretion. twice-a-month administration. 28.10.1999 01.01.9999 Treatment of growth failure in children due to have growth failure due to inadequate Somatropin (rDNA origin) injection Norditropin inadequate growth hormone secretion. Treatmentsecretion of and endogenous prevention growth of 10.07.1987 01.01.9999 respiratory failure due to pulmonary Surface active extract of saline Treatment and prevention of respiratory failure due to surfactant deficiency in preterm lavage of bovine lungs Infasurf pulmonary surfactant deficiency in preterm infants. Forinfants. use as an aid in ophthalmic 07.06.1985 01.01.9999 surgery by staining the epiretinal Selectively staining epiretinal membranes during membranes during ophthalmic Trypan blue MembraneBlue Treatmentophthalmic of surgical congenital victrectomy antithrombin procedures deficiency to Preventionsurgical vitrectomy of peri-operative procedures, and peri- 02.08.2006 20.02.2009 prevent the occurrence of serious, potentially life- partum thromboembolic events, in threatening venous thromboembolisms which may hereditary antithrombin deficient Recombinant human antithrombin ATryn develop as a result of surgical or obstetrical procedures Treatmentpatients. of acute bleeding episodes 07.12.2007 06.02.2009 in patients with congenital fibrinogen human fibrinogen concentrate, deficiency (afibrinogenemia and pasteurized RiaSTAP Treatment of fibrinogen deficient patients Treatmenthypofibrinogenemia of adult patients with B-cell 13.03.2008 16.01.2009 chronic lymphocytic leukemia (CLL) whose disease has not responded to Fludarabine phosphate oral tablets ForTreatment use to improveof B-cell thechronic yield lymphocytic of progentor leukemia cells in the Toor hasenhance progressed mobilization during of or after 18.12.2007 18.12.2008 apheresis product for subsequest stem cell hematopoietic stem cells to the transplantation following myelosuppressive or peripheral blood for collection and plerixafor Mozobil myeloablative chemotherapy Treatmentsubsequent of autologous thrombocytopenia in 10.07.2003 15.12.2008 patients with chronic immune eltrombopag Promacta Treatment of idiopathic thrombocytopenia purpura (idiopathic) thrombocytopenic purpura 05.05.2008 20.11.2008 Adjunctive therapy of seizures associated with Lennox-Gastaut rufinamide Banzel Treatment of Lennox-Gastaut Syndrome. syndrome. 08.10.2004 14.11.2008 Routine prophylaxis against angioedema attacks in patients with C1 esterase inhibitor (human) Cinryze Treatment of angioedema Hereditary Angioedema (HAE) 16.07.2004 10.10.2008 To be used in the detection of primary or metastatic pheochromocytomas or neuroblastomas as an adjunct to other Iobenguane I 123 AdreView For the diagnosis of pheochromocytomas diagnostic tests 01.12.2006 19.09.2008 To be used in the detection of primary or metastatic pheochromocytomas or neuroblastomas as an adjunct to other Iobenguane I 123 Adreview For the diagnosis of neuroblastomas diagnostic tests 01.12.2006 19.09.2008 Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to improve neuromuscular disability Treatment of chronic inflammatory demyelinating and impairment and for maintenance Immune Globulin (Human) Gamunex polyneuropathy Treatmenttherapy to preventof thrombocytopenia relapse in 27.07.2004 12.09.2008 patients with chronic immune (idiopathic) thrombocytopenic purpura romiplstim Nplate Treatment of immune thrombocytopenic purpura (ITP) who have had an insufficient 27.03.2003 22.08.2008 Treatment of chorea associated with Tetrabenazine Xenazine Treatment of Huntington's disease Huntington's disease 11.12.1997 15.08.2008 Treatment of unresectable Sorafenib Nexavar Treatment of hepatocellular carcinoma hepatocellular carcinoma 20.04.2006 24.03.2008 Treatment of patients with chronic Bendamustine hydrochloride Treanda Treatment of chronic lymphocytic leukemia Levoleucovorinlymphocytic leukemia rescue is indicated 17.08.2007 20.03.2008 after high-dose methotrexate therapy For use in conjunction with high-dose methotrexate in in osteosarcoma. Levoleucovorin is Levoleucovorin the treatment of osteosarcoma. also indicated to diminish the toxicity 01.08.1991 07.03.2008 Treatment of Cryopyrin-Assisted Rilonacept Arcalyst Treatment of CIAS1-Associated Periodic Syndromes Periodic Syndromes (CAPS) 20.12.2004 27.02.2008 Treatment of Juvenile Idiopathic Adalimumab Humira Treatment of juvenile rheumatoid arthritis Arthritis 21.03.2005 21.02.2008 For use as an adjunctive treatment for radioiodine ablation of thyroid tissue Treatment of well-differentiated papillary, follicular or remnants in patients who have Thyrotropin alfa Thyrogen combined papillary/follicular carcinomas of the thyroid Indicatedundergone to thyroidectomy reduce blood for well- 03.08.2001 14.12.2007 phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) sapropterin Kuvan Treatment of hyperphenylalaninemia Fordue theto tetrahydrobiopterin- use for chronic phase (BH4-) (CP) 29.01.2004 13.12.2007 and accelerated phase (AP) Philadelphia chromosome positive Nilotinib Tasigna Treatment of chronic myelogenous leukemia Reductionchronic myelogenous in risk of invasive leukemia breast (CML) 27.04.2006 29.10.2007 cancer in postmenopausal women Reduction of the risk of breast cancer in with osteoporosis and reduction in risk Raloxifene Evista postmenopausal women of invasive breast cancer in 14.07.2005 13.09.2007 Treatment of anthracycline extravasation during Treatment of extravasation resulting dexrazoxane Totect chemotherapy Long-termfrom IV anthracycline treatment of chemotherapy acromegalic 25.03.2004 06.09.2007 patients who have had an inadequate response to or cannot be treated with Lanreotide Somatuline Depot Treatment for acromegly Treatmentsurgery and/or of pulmonary radiotherapy arterial 11.09.2000 30.08.2007 hypertension (WHO group I) in patients with WHO class II or III ambrisentan Letairis Treatment of pulmonary arterial hypertension symptoms to improve exercise 16.07.2004 15.06.2007 Treatment of short stature in patients with Noonan Treatment of short stature in patients Somatropin Norditropin syndrome with Noonan syndrome 09.08.2006 31.05.2007 Treatment of advanced renal cell Temsirolimus Torisel Treatment of renal cell carcinoma Forcarcinoma use in combination with 16.12.2004 30.05.2007 bortezomib for the treatment of Doxorubicin HCL liposome patients with multiple myeloma who injection Doxil Treatment of multiple myeloma have not previously received 29.12.2004 17.05.2007 Treatment of central precocious Histrelin Supprelin LA Treatment of central precocious puberty Preventionpuberty of hepatitis B recurrence 18.11.2005 03.05.2007 following liver transplantation in hepatitis B immune globulin Prevention of hepatitis B recurrence following orthotopic HBsAG-positive liver transplant (human) HepaGam liver transplant patients 24.03.2008 06.04.2007 For replacement therapy in congenital protein C deficiency for the prevention and treatment of Prevention and treatment of venous Protein C concentrate Ceprotin thrombosis, pulmonary emboli, and purpura fulminans. thrombosis and purpura fulminans 23.06.1992 30.03.2007 Treatment of paroxysmal nocturnal eculizumab Soliris Treatment of paroxysmal nocturnal hemoglobinuria hemoglobinuria to reduce hemolysis 20.08.2003 16.03.2007 For surgical and/or invasive procedures in patients with von Willebrand Disease (VWD) in whom Antihemophilic factor (human) Alphanate Treatment of von Willebrand's disease Treatmentdesmopressin of mildly is either to moderately ineffective or 05.01.1996 31.01.2007 active ulcerative colitis in patients 5 years of age and older. Safety and Balsalazide disodium Colazal Treatment of pediatric patients with ulcerative colitis Effectiveness of Colazal beyond 8 12.08.2005 20.12.2006 Treatment on known or suspected Hydroxocobalamin Cyanokit Treatment of acute
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