Skip to content

FDA August 2013 Products Receiving Orphan Designation

August 31, 2013

The chart below identifies the FDA August 2013 Products Receiving Orphan Designation. The chart is generated from the FDA’s Orphan Drug Product Designation Database Application and is current as of September 6, 2013. The chart is created by performing a search for the following date range :

Start Date: 08/01/2013 & End Date: 08/31/2013.

Row Num

Generic Name

Designation Date

Orphan Designation

1

(S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one 08-01-2013 Follicular Lymphoma

2

Conjugate of a dengue virus specific small chemical ligand and an amphiphilic PEG based polymer 08-06-2013 Dengue Fever

3

Human Hemin 08-06-2013 Prevention of Ischemia Reperfusion Injury

4

L. reuteri 08-01-2013 Prevention of Necrotizing Enterocolitis in Preterm Infants

5

bispecific antibody (monoclonal antibody) 08-08-2013 HER2-expressing advanced adenocarcinoma of stomach & gastroesophageal junction

6

bispecific antibody (monoclonmal antibody) 08-08-2013 HER2-expressing adenocarcinoma ofesophagus

7

dantrolene sodium suapension for injection 08-16-2013 Malignant Hyperthermia Syndrome

8

deflazacort 08-16-2013 Duchenne Muscular Dystrophy

9

expanded human allogeneic neural retinal progenitor cells extracted from neural retina 08-22-2013 Retinitis Pigmentosa

10

pentamidine 08-12-2013 Liver & Intrahepatic Bile Duct Cancer

11

pentamidine 08-12-2013 Ovarian Cancer

12

pomalidomide 08-22-2013 Systemic Sclerosis

13

recombinant human nerve growth factor 08-08-2013 RetinitisPpigmentosa

14

ruxolitinib 08-16-2013 Pancreatic Cancer

15

small molecule inhibitor of histone methyltransferase DOT1L 08-08-2013 Acute Lymphoblastic Leukemia (ALL)

16

synthetic double-stranded siRNA oligonucleotide against antithrombin (AT) mRNA 08-16-2013 Hemophilia A

17

synthetic double-stranded siRNA oligonucleotide against antithrombin mRNA 08-12-2013 Hemophilia B

18

uridine triacetate 08-09-2013 Hereditary Protic Aciduria

19

trebananib 08-30-2013 Ovarian Cancer

20

angiotensin (1-7) 08-30-2013 Mobilization of Hematopoietic Stem Cells (CD34+)

**  “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.

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: