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FDA December 2014 Products Receiving Orphan Designation

December 26, 2014





The chart below identifies FDA Decemberr 2014 Products Receiving Orphan Designation as of 12/26/14 in ascending “Orphan Drug Designation Date” order.

FDA December 2014 Products Receiving Orphan Designation

# Generic Name/ODD Date Sponsor Company Indication
1  Humanized Fc engineered monoclonal antibody against CD19/ 12.01 MorphoSys AG (Germany) Diffuse large B-cell lymphoma
2 Imiquimod/ 12.03 Telormedix SA (Switzerland) Carcinoma in situ (CIS) of the urinary bladder
3 Liposome encapsulated paclitaxel/ 12.03 Insys Therapeutics Gastric Cancer
4 Non-replicating adeno-associated viral vector, serotype 8, expressing human myotubularin gene/ 12.03 Audentes Therapeutics X-linked myotubular myopathy
5 Xenon Gas/ 12.03 Neuroprotexeon (UK) Hypoxic ischemic encephalopathy
6 1 8-(p[131I]-iodophenyl)octadecyl phosphocholine/ 12.03 Cellectar Biosciences Multiple Myeloma
7 Theranost 68Ga-RGD/ 12.08 Advanced Imaging Projects LLC Clinical management of patients with neuroblastoma
8 Recombinant nematode anticoagulant protein c2 (rNAPc2)/ 12.08 ARCA Biopharma Viral hemorrhagic fever post-exposure to Ebola virus
9 Ataluren (Translarna)/ 12.10 PTC Therapeutics Mucopolysaccharidosis  (MPS) type I
10 Non-peptide small molecule orally available agonist of the parathyroid hormone receptor type I/ 12.15 Chugai Pharma USA Hypoparathyroidism
11 Hepcortespenlisimut-L/ 12.17 Immunitor (Canada) Hepatocellular carcinoma
12 Cytochrome P450 isoform 2B1 gene transfected human embryonic kidney 293 cells encapsulated in polymeric cellulose sulphate/ 12.17 Nuvilex Pancreatic cancer in combination with ifosfamide
13 Docosahexaenoic acid, DHA/ 12.17 Sancilio & Co Primary sclerosing cholangitis
14 Veliparib/ 12.17 AbbVie Brain metastases when used in combination with DNA-damaging agents
15 N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methylpiperazin-1yl)-2-(tetrahydro-2H-pyran-4-ylamino)benzamide/ 12.22 Ignyta Neuroblastoma
16 Oncolytic adenovirus coding for granulocyte macrophage colony stimulating factor (ONCOS-102)/ 12.22 Oncos Therapeutics (Finland) Malignant Mesothelioma
17 Chromium picolinate and chromium histidinate/ 12.22 JDS Therapeutics Pediatic polycystic ovary syndrome (0 – 16 years of age)
18 (Human recombinant mesencephalic, astrocyte derived neurotrophic factor / 12.22 Amarantus BioScience Holdings Retinitis pigmentosa
19 Pleconaril/ 12.22 AntiVirus Therapeutics Symptomatic entoviral infection in the neonate
20 OTL38; conjugate of pteroi acid and S0456 near infrared dye/ 12.23 On Target Laboratories Detecting folic receptor alpha positive lesions in ovarian cancer patients
21 3-[2-(4-carbamimidoyl-phenylcarbamoyl)-5-methoxy-4-vinyl-phenyl]-6-(cyclopropylmethyl-carbamoyl)-pyridine-2-carboxylic acid/ 12.23 BioCryst Pharmaceuticals Acute attacks of angioedema in hereditary angioedema


** 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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