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10 New FDA Orphan Drug Designations: Week of 06/08/15

June 13, 2015







The chart below identifies 10 new FDA Products Receiving Orphan Designation for the week of 06/08 – 06/12/15 as of 06/13/15 in ascending “Orphan Drug Designation Date” order.

FDA Products Receiving Orphan Drug Designation (Week of 06/08 – 06/12/15)

 # Generic Name/ODD Date Sponsor Company Indication
1 Adenoviral vector expressing the E. Coli purine nucleoside phosphorylase gene and fludarabine / 06.08 PNP Therapeutics Anatomically accessible oral & pharyngeal cancers
2 Fully human IgG2 monoclonal antibody that binds insulin receptors/ 06.09 XOMA Congenital hyperinsulinism
3 Double stranded oligomer AD00370 RNA interference-based liver targeted therapeutic/ 06.09 Arrowhead Research Corporation Alpha-1 Antitrypsin Deficiency
4 Recombinant human CD24Fclg (humanized fusion protein consisting of the extracellular domain of CD24 linked to IgG Fc domain/ 06.09 Oncolmmune Graft-versus-host Disease
5 Isocitrate dehydrogenase 1 (IDH1)-mutant inhibitor/ 06.09 Agios Pharmaceuticals Acute Myeloid Leukemia (AML)
6 Tumor-inflitrating lymphocytes; LN-144/ 06.09 Lion Biotechnologies Malignant melanoma Stages IIb to IV
7 Staphylococcal aureus protein A/ 06.10 Protalex Inc Immune thrombocytopenic purpura
8 (6aR, 10aR)-3-(1’,1’-dimethylheptyl)-Δ8-tetrahydro-cannabinol-9-carboxylic acid / 06.10 Corbus Pharmaceuticals Systemic sclerosis
9 Imetelstat/ 06.11 Janssen Research & Development Myelofibrosis
10 Obinutuzumab/ 06.11 Genentech Splenic marginal zone lymphoma


** 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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