FDA May 2015 Products Receiving Orphan Designation

Orphan Druganaut Blog

The chart below identifies FDA May 2015 Products Receiving Orphan Designation as of 06/02/15 in ascending “Orphan Drug Designation Date” order.

FDA May 2015 Products Receiving Orphan Designation

#Generic Name/ODD DateSponsor CompanyIndication
1Tacrolimus/ 05.04Stanford University School of MedicinePulmonary Arterial Hypertension
2Tadalafil/ 05.04Eli Lilly & CoDuchenne Muscular Dystrophy
3Pantothenate Phosphate / 05.04RetrophinPantothenate Kinase Associated Neurodegeneration
4Pelareorep/ 05.04Oncolytics BiotechGastric Cancer
54-(pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one/ 05.04Gilead SciencesCongenital Long QT Syndrome
6LOAd703, a modified adenovirus 5/35 containing a CMV promoter-driven transgene cassette with the human transgenes for a membrane-bound CD40 ligand (TMZ-CD40L) and full length 4-1BBL/ 05.04Lokon Pharma AB (Sweden)Pancreatic Cancer
7Humanized monoclonal antibody that targets the a-subunit of the human IL-3 receptor also known as the CD123 antigen; (JNJ-56022473)/ 05.05Janssen Research & DevelopmentAcute Myeloid Leukemia
8Autologous tumor cells…

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