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FDA July 2014 Products Receiving Orphan Designation

August 1, 2014






The chart below identifies FDA July 2014 Products Receiving Orphan Designation as of 08/01/14 in ascending “Orphan Drug Designation Date” order.

FDA July 2014 Products Receiving Orphan Designation

# Generic Name/ODD Date Sponsor Company Indication
1 Cannabidiol/ 07.01 Insys Therapeutics Dravet Syndrome
2 2-(2-phenylvinyl)-4-[4-methylpiperazin-1-yl)]-6-(5-methyl-2H-pyrazol-3-yl-amino)-pyrimidine L(+) tartrate salt/ 07.01 CASI Pharmaceuticals Hepatocellular Carcinoma
3 bendamustine for 50 ml admixture / 07.02 Eagle Pharmaceuticals Chronic Lymphocytic Leukemia
4 bendamustine for 50 ml admixture / 07.02 Eagle Pharmaceuticals Different Types of Lymphoma
5 Carbenoxolone/ 07.02 Oxalys Pharmaceuticals (Canada) Huntington’s Disease
6 Adalimumab/ 07.10 Mucora (Israel) Behcet’s Disease
7 Siponimod / 07.10 Novartis Dermatomyositis
8 maytansinoid conjugated humanized monoclonal antibody against FOLRI / 07.14 ImmunoGen Ovarian Cancer
9 oxfendazole / 07.14 Robert H. Gilman, MD, DTMH and Johns Hopkins School of Public Health Cysticercosis (including neurocysticercosis)
10 polymer surgical mesh delivering paclitaxel / 07.15 AcuityBio local administration at the time of curative surgery in the treatment of stage 0 to III non-small cell lung cancer
11 2-[(6S)-4-(4-chlorophenyl)-2,3,9-trimethyl-6H-thienol[3,2,-f]-[1,2,4]triazolo[4,3-a][1,4]diazepin-6-yl]-N-(4-hydroxyphenyl)-acetamide dihydrate/ 07.16 OncoEthix (Switzerland) Acute myeloid leukemia
12 single stranded, chemically modified oligonucleotide that binds to and inhibits the function of micro RNA-21/ 07.17 Regulus Therapeutics Alport Syndrome
13 antibody drug conjugate consisting of fully human anti-guanylyl cyclase C monoclonal antibody linked to the cytotoxic drug monomethyl auristatin E/ 07.21 Millennium Pharmaceuticals Gastric Cancer
14 palovarotene / 07.21 Clementia Pharmaceuticals (Canada) fibrodysplasia ossificans progressiva
15 pegargiminase/ 07.21 Polaris Group mesothelioma
16 triterpenoid saponin/ 07.23 Avicin Therapeutics mantle cell lymphoma
17 riociguat/ 07.24 Bayer HealthCare Pharmaceuticals systemic sclerosis
18 monomethyl auristatin E conjugated to a monoclonal antibody which targets guanylyl cyclase C/ 07.29 Millennium Pharmaceuticals pancreatic cancer
19 Pirfenidone/ 07.31 Genoa Pharmaceuticals idiopathic pulmonary fibrosis
20 Binimetinib/ 07.31 Array Biopharma Ovarian Cancer


** “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-3.0] | Wikimedia Commons.

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