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FDA October 2012 Products Receiving Orphan Designations

November 9, 2012

       The chart below identifies the FDA October 2012 Products Receiving Orphan Designations.  The chart is generated from the FDA’s Orphan Drug Product Designation Database Application and is current as of November 9, 2012. The chart is created by performing a search for the following date range :  

Start Date: 10/01/2012 & End Date: 10/31/2012.

Row Num Generic Name Designation Date Indication
1 (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid 10-31-2012 Treatment of progressive familial intrahepatic cholestatis
2 (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid 10-31-2012 Treatment of primary biliary cirrhosis
3 2′-O-methyl phosphorothioate 5′-GCUAGGUUUACGGGACCUCU-3′ 10-31-2012 Treatment of amyotrophic lateral sclerosis
4 coagulation factor IX (recombinant) 10-31-2012 Prophylactic use to prevent or reduce the frequency of bleeding episodes in patients with hemophilia B (routine prophylaxis in patients where there is no evidence or suspicion of bleeding)
5 crenolanib 10-31-2012 Treatment of acute myelogenous leukemia
6 crizotinib 10-31-2012 Treatment of neuroblastoma
7 pralmorelin hydrochloride 10-18-2012 As a diagnostic agent for the detection of growth hormone deficiency
8 recombinant human GM-CSF, molgramostim 10-31-2012 Treatment of pulmonary alveolar proteinosis
9 sirolimus 10-31-2012 Treatment of lymphangioleiomyomatosis
10 sodium sulfate, potassium sulfate, and magnesium sulfate 10-31-2012 For cleansing of the colon in preparation for colonoscopic diagnosis of colonic disease in children and adolescents
11 tetracosactide hexaacetate (beta 1-24-corticotrophin) 10-31-2012 Treatment of infantile spasms

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