Skip to content

FDA July 2013 Products Receiving Orphan Designation

August 1, 2013

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

Start Date: 07/01/2013 & End Date: 07/31/2013.

Row Num

Generic Name

Designation Date

Orphan   Designation

1

(5R)-5-(4-{[2-fluorophenyl)methyl]oxy}phenyl)-L-prolinamide,   hydrochloride 07-24-2013 Trigeminal Neuralgia

2

N-methyl-4-({4-[({3-methyl(methylsulfonyl)amino]pyrazin-2-yl}methyl)amino]-5-(trifluoromethyl)pyrimidin-2-yl}amino)benzamide   hydrochloride 07-18-2013 Mesothelioma

3

alisertib 07-12-2013 Small Cell Lung Cancer

4

allopregnanolone 07-12-2013 Neimann-Pick Disease, type C

5

angiotensin (1-7)[A(1-7)] 07-25-2013 Duchenne Muscular Dystrophy

6

bezafibrate 07-24-2013 Barth Syndrome

7

denileukin diftitox 07-12-2013 Cutaneous T-Cell Lymphoma

8

granulocyte-macrophage colony stimulating factor-coding   oncolytic adenovirus, Ad5/3-D24-GMCSF 07-24-2013 Soft Tissue Sarcoma

9

hydroxycarbamide (hydroxyurea) 07-24-2013 Sickle Cell Disease in patients under 18 years of age

10

pertuzumab 07-12-2013 Gastric Cancer

11

sulthiame 07-25-2013 Benign Epilepsy of Childhood with Centrotemporal Spikes   (BECTS)

12

topiramate injection 07-24-2013 Generalized Tonic-Clonic Seizures for Hospitalized Epilepsy   Patients

**  “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: