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FDA September 2012 Products Receiving Orphan Designations

October 15, 2012

       The chart below identifies the FDA September 2012 Products Receiving Orphan Designations.  The chart is generated from the FDA’s Orphan Drug Product Designation Database Application.  The chart is created by performing a search for the following date range : 

Start Date: 09/01/2012 & End Date: 09/31/2012. 

Row Num Generic Name Designation Date Indication
1 (E)-5-[[(2,4,6-Trimethoxystyryl)-sulfonyl]methyl] -2-methoxyphenyl dihydrogen phosphate 09-04-2012 Treatment of acute radiation symdrome
2 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide 09-20-2012 Treatment of chronic lymphocytic leukemia
3 ADF-APO-CCN-GUC-K67-MET-MMP-MUC-RGS; HLA class I/II binding tumor associated peptides 09-28-2012 Treatment of renal cell carcinoma in HLA-A*2 positive patients
4 H-Leu-Pro-Pro-Ser-Arg-OH 09-20-2012 Treatment of Kaposi sarcoma
5 Japanese encephalitis vaccine, inactivated, adsorbed 09-25-2012 Prevention of Japanese encephalitis virus in pediatric patients.
6 Synthetic double-stranded siRNA oligonucleotide against caspase 2 mRNA 09-25-2012 Treatment of ischemic optic neuropathy
7 alfimeprase 09-20-2012 Treatment of ST-elevation myocardial infarcted patients who are undergoing primary percutaneous coronary intervention
8 amatuximab 09-28-2012 Treatment of mesothelioma
9 canakinumab 09-04-2012 Treatment of TNF-receptor associated periodic syndrome (TRAPS)
10 carbon monoxide 09-28-2012 Treatment of sickle cell disease
11 crizotinib 09-28-2012 Treatment of anaplastic large cell lymphoma
12 dantrolene sodium 09-25-2012 Treatment of heat stroke
13 glycosylated recombinant human interleukin-7 09-27-2012 Treatment of progressive multifocal leukoencephalopathy
14 liposomal α-galactosylceramide 09-28-2012 Prevention of graft-versus-host disease
15 mecasermin rinfabate 09-20-2012 Prevention of retinopathy of prematurity in premature infants born at risk for the disease
16 menaquinone 09-04-2012 Treatment of calciphylaxis
17 metyrapone 09-25-2012 Treatment of Cushing’s syndrome
18 milciclib maleate 09-20-2012 Treatment of thymic epithelial tumors.
19 mouse-human chimeric monoclonal anti-GD2 IgG1 antibody 09-20-2012 Treatment of neuroblastoma.
20 paclitaxel poliglumex 09-20-2012 Treatment of glioblastoma multiforme
21 quinacrine 09-28-2012 Treatment of hepatocellular carcinoma
22 reparixin 09-25-2012 Prevention of graft loss in pancreatic islet transplantation
23 trametinib and dabrafenib 09-20-2012 Treatment of Stage IIb through IV melanoma.
24 vancomycin hydrochloride (inhalational) 09-20-2012 Treatment of persistent methicillin-resistant S. aureus lung infection in patients with cystic fibrosis

 Copyright  © 2012-2013, Ann-Teresa Cusenza and Orphan Druganaut Blog.  All rights reserved.

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