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FDA May 2014 Products Receiving Orphan Designation

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Originally posted on Orphan Druganaut Blog:

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The chart below identifies FDA May 2014 Products Receiving Orphan Designation as of 05/31/14 in ascending “Orphan Drug Designation Date” order.

FDA May 2014 Products Receiving Orphan Designation 

# Generic Name/ODD Date Sponsor Company Indication
1 Filanesib/ 05.06 Array BioPharma Multiple Myeloma
2 Autologous dendritic cells pulsed with allogeneic tumor cell lysate/ 05.06 Amphera BV (Netherlands) Malignant Mesothelioma
3 Ex vivo cultured human mesenchymal stromal cells / 05.08 iCell Science AB (Sweden) Prevention of graft rejection following solid organ transplantation
4 Adalimumab/ 05.13 AbbVie Uveitis
5 Diazoxide choline / 05.13 Essentialis Prader-Willi Syndrome
6 Vasoactive intestinal peptide (VIP)-elastin-like peptide (ELP) fusion protein / 05.13 PhaseBio Pharmaceuticals Pulmonary arterial hypertension
7 (Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N-(pyrazin-2-yl)acrylohydrazide / 05.14 Karyopharm Therapeutics Diffuse large B-cell lymphoma
8 177Lu-tetraxetan-tetulomab / 05.14 Nordic Nanovector AS (Norway) Follicular Lymphoma
9 Selinexor; (Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N-(pyrazin-2-yl)acrylohydrazide / 05.14 Karyopharm Therapeutics Acute myeloid leukemia
10 Menadione Sodium Bisulfite/ 05.14

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