Skip to content

FDA January 2013 Products Receiving Orphan Designation

February 2, 2013

The chart below identifies the FDA January 2013 Products Receiving Orphan Designation. The chart is generated from the FDA’s Orphan Drug Product Designation Database Application and is current as of February 2, 2013. The chart is created by performing a search for the following date range :

Start Date: 01/01/2013 & End Date: 01/31/2013.

Generic Name

Designation Date

Indication

1) 10 synthetic peptides targeting 5 tumor asociated   antigens 01-23-2013 Non-small Cell Lung Cancer with HLA-A2
2) 5-aminolevulinic acid 01-15-2013 Visualization of malignant tissue for malignant glioma
3) Efdispo 01-15-2013 Ewings Sarcoma
4) Exon 45 specific phosphorothioate oligonucleotide 01-23-2013 Duchenne Muscular Dystrophy
5) Exon 52 specific phosphorothiate oligonucleotide 01-23-2013 Duchenne Muscular Dystrophy
6) Exon 55 specific phosphorothioate oligonucleotide 01-23-2013 Duchenne Muscular Dystrophy
7) O-(3-piperidino-2-hydroxyl-1-propyl)-nicotinic acid   amidoxime hydrochloride 01-15-2013 Duchenne Muscular Dystrophy
8) P140K MGMT transduced human CD34 cells 01-09-2013 Bone Marrow Protection for Glioblastoma Multiforme
9) [met5]-enkephalin 01-24-2013 Pancreatic Cancer
10) apremilast 01-17-2013 Behcet’s Disease
11) beloranib 01-15-2013 Prader-Willi syndrome
12) eflornithine plus sulindac 01-22-2013 Familial Adenomatous Polyposis
13) enalapril maleate (powder for oral solution) 01-30-2013 Hypertension in pediatric atients
14) exon 53 specific phosphorothioate oligonucleotide 01-23-2013 Duchenne Muscular Dystrophy
15) ezatiostat hydrochloride 01-09-2013 Myelodysplastic Syndrome
16) lisuride 01-17-2013 Pulmonary Arterial Hypertension
17) modified recombinant human C-type natriuretic peptide (CNP) 01-17-2013 Achondroplasia
18) nivolumab 01-23-2013 Stage IIb to IV Melanoma
19) onartuzumab 01-23-2013 Gastric cancer
20) paclitaxel nanoparticles 01-03-2013 Pancreatic Cancer
21) rilonacept 01-09-2013 Familial Mediterranean Fever
22) synthetic peptide;   cyclo-Cys-Gly-Gln-Arg-Glu-Thr-Pro-Glu-Gly-Ala-Glu-ALA-Lys-Pro-Trp-Tyr-Cys 01-15-2013 High Altitude Pulmonary Edema
23) tafenoquine 01-15-2013 Malaria

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

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

Advertisements
Leave a Comment

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: