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FDA June 2013 Products Receiving Orphan Designation

July 1, 2013

The chart below identifies the FDA June 2013 Products Receiving Orphan Designation. The chart is generated from the FDA’s Orphan Drug Product Designation Database Application and is current as of July 1, 2013. The chart is created by performing a search for the following date range :

Start Date: 06/01/2013 & End Date: 06/30/2013.


Row Num

Generic Name

Designation Date

Orphan   Designation


(1-methyl-2-nitro-1H-imidazole-5-yl)methyl N,N’-bis(2-broethyl) diamidophosphate 06-05-2013 Pancreatic Cancer


(S)-4-(5-chloro-2-(isopropylamino)pyridin-4-yl)-N-(1-(3-chlorophenyl)-2-hydroxyethyl)-1H-pyrrole-2-carboxamide hydrochloride 06-24-2013 Stage IIb – Stage IV BRAF Mutant Melanoma


Humanized 3F8-IgG1 monoclonal antibody 06-24-2013 Neuroblastoma


IL-12   secreting dendritic cells loaded with autologous tumor lysate 06-24-2013 Malignant Glioma


Cyclo(-y-aminobutyryl-L-phenylalanyl-D-tryptophanyl-L-lysyl-L-threonly-L-phenylalanyl-N-3-carboxypropyl)-glycine amide, acetate salt 06-24-2013 Acromegaly


Eculizumab 06-24-2013 Neuromyelitis Optica


Flunarizine Hydrochloride 06-24-2013 Alternating Hemiplegia


Human interleukin-3 genetically conjugated to diphtheria toxin protein 06-06-2013 Blastic Plasmacytoid Dendritic Cell Neoplasm


Human platelet antigen-1a immunoglobulin (anti-HPA-1a) 06-27-2013 Prevention of Fetal & Neonatal Alloimmune   Thrombocytopenia


Intravenous Carbamazepine 06-27-2013 Epilepsy Patients who cannot take anything by mouth (NPO)


Liposomal Busulfan 06-24-2013 Conditioning regimen for patients with malignancies   undergoing autologous or allogenic hematopoietic stem cell transplantation


Repository Corticortropin Injection 06-28-2013 Amyotrophic Lateral Sclerosis (ALS)


Sodium Phenylbutyrate 06-06-2013 Urea Cycle Disorders

**  “Generic Name” Column Link = Is the FDA Orphan Drug Product Designation Database Record.

Please Note: “Erlenmeyer Flasks” From Argonne US National Lab  [Public domain in the US] | Wikimedia Commons.

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