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FDA November 2012 Products Receiving Orphan Designation

December 6, 2012

       The chart below identifies the FDA November 2012 Products Receiving Orphan Designation.  The chart is generated from the FDA’s Orphan Drug Product Designation Database Application and is current as of December 5, 2012. The chart is created by performing a search for the following date range :   

Start Date: 11/01/2012 & End Date: 11/30/2012.

Row Num Generic Name Designation Date Indication
1 1′-{[5-(trifluoromethyl)-2-furyl]methyl}spiro[furo[2,3-f][1,3]benzodioxole-7,3′-indol]-2′(1’H)-one 11-19-2012 Treatment of erythromelalgia
2 Hantaan virus and Puumala virus DNA vaccines 11-13-2012 Prevention of hemorrhagic fever with renal syndrome caused by Hantaan virus and Puumala virus.
3 Recombinant Human Factor VIIa Variant 11-30-2012 Routine prophylaxis to prevent bleeding episodes in patients with hemophilia A and B patients with inhibitors
4 adeno-associated virus transgene of follistatin 11-19-2012 Treatment of Duchennes and Becker’s muscular dystrophy
5 beclomethasone 17,21-dipropionate 11-19-2012 Prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster
6 brentuximab vedotin 11-19-2012 Treatment of mycosis fungoides
7 chimeric monoclonal antibody to claudin 18 splice variant 2 11-20-2012 Treatment of Gastric Cancer
8 combretastatin A 1 diphosphate 11-19-2012 Treatment of acute myelogenous leukemia
9 extract of sorghum bicolor extract 11-19-2012 Treatment of sickle cell disease
10 humanized anti programmed cell death 1 monoclonal IgG4 antibody 11-19-2012 Treatment of Stage IIB through IV malignant melanoma
11 melphalan 11-19-2012 Treatment of retinoblastoma
12 melphalan 11-19-2012 Treatment of Stage IIB through IV melanoma
13 sodium thiosulfate 11-19-2012 Treatment of calciphylaxis
14 tabalumab 11-19-2012 Treatment of multiple myeloma

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