FDA May 2015 Products Receiving Orphan Designation

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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 Date Sponsor Company Indication
1 Tacrolimus/ 05.04 Stanford University School of Medicine Pulmonary Arterial Hypertension
2 Tadalafil/ 05.04 Eli Lilly & Co Duchenne Muscular Dystrophy
3 Pantothenate Phosphate / 05.04 Retrophin Pantothenate Kinase Associated Neurodegeneration
4 Pelareorep/ 05.04 Oncolytics Biotech Gastric Cancer
5 4-(pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one/ 05.04 Gilead Sciences Congenital Long QT Syndrome
6 LOAd703, 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/ 05.04 Lokon Pharma AB (Sweden) Pancreatic Cancer
7 Humanized monoclonal antibody that targets the a-subunit of the human IL-3 receptor also known as the CD123 antigen; (JNJ-56022473)/ 05.05 Janssen Research & Development Acute Myeloid Leukemia
8 Autologous tumor cells…

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