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8 New FDA Orphan Drug Designations: Week of 05/04/15

May 8, 2015





The chart below identifies 8 new FDA Products Receiving Orphan Designation for the week of 05/04/15 as of 05/08/15 in ascending “Orphan Drug Designation Date” order.

FDA Products Receiving Orphan Drug Designation (Week of 05/04/15)

 # Generic Name/ODD Date Sponsor Company Indication
1 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
2 Tacrolimus/ 05.04 Stanford University School of Medicine Pulmonary Arterial Hypertension (PAH)
3 Tadalafil/ 05.04 Eli Lilly & Co Duchenne Muscular Dystrophy (DMD)
4 Pantothenate Phosphate/ 05.04 Retrophin Pantothenate kinase associated neurodegeneration (PKAN)
5 Pelareorep/ 05.04 Oncolytics Biotech (Canada) Gastric Cancer
6 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
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 fused with polyethylene glycol to human allogeneic FO-1, DNA plasmid transfected tumor cell line/ 05.06 Sebastiano Gattoni-Celli, MD Glioblastoma


** Generic Name/ODD Date” Column Link = Is the FDA Orphan Drug Product Designation Database Record.

Please Note : “Two small test tubes held in spring clamps” courtesy of  Amitchell125 at English Wikipedia [CC-BY-SA-30] | Wikimedia Commons.

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