Skip to content

FDA December 2012 Products Receiving Orphan Designation

January 4, 2013

The chart below identifies the FDA December 2012 Products Receiving Orphan Designation. The chart is generated from the FDA’s Orphan Drug Product Designation Database Application and is current as of January 1, 2013. The chart is created by performing a search for the following date range :

Start Date: 12/01/2012 & End Date: 12/31/2012.

Row Num

Generic Name

Designation Date

Indication

1

     PGC-C12E-terlipressin

  12-27-2012   Refractory ascites due to all etiologies   except for cancer

2

     S-nitrosoglutathione   12-28-2012   Severe pre-eclampsia

3

     Yttrium(90Y)-DTPA-radiolabelled chimeric monoclonal   antibody against frizzled homologue 10   12-03-2012   Soft tissue sarcoma

4

     adeno-associated viral vector containing DNA encoding an   RNAi targeting rhodopsin in combination with an adeno-associated viral vector   containing DNA encoding a rhodopsin gene   12-13-2012   Retinitis pigmentosa

5

     adeno-associated viral vector serotype 9 containing   human N-acetylglucosaminidase alpha gene   12-27-2012   Mucopolysaccharidosis type IIIB (Sanfilippo   B syndrome)

6

     afatinib   12-03-2012   Epidermal growth factor receptor mutation   positive non-small cell lung cancer

7

     apolipoprotein E mimetic peptide   12-03-2012   Homozygous familial hypercholesterolemia

8

     diazoxide   12-03-2012   Prader Willi Syndrome

9

     elafin   12-28-2012   Pulmonary arterial hypertension

10

     glucagon   12-05-2012   Hypoglycemia in the congenital   hyperinsulinism population

11

     hexasodium phytate   12-02-2012   Calciphylaxis

12

     human coagulation factor VIII   12-03-2012   Immune tolerance induction in hemophilia A   patients with inhibitors

13

     ibrutinib   12-03-2012   Mantle cell lymphoma

14

     lenvatinib   12-27-2012   Follicullar, medullary, anaplastic, and   metastatic or locally advanced papillary thyroid cancer

15

     methylene blue0.5%   12-18-2012   Hereditary methemoglobinemia

16

     perampanel   12-07-2012   Lennox-Gastaut Syndrome

17

     porcine GM1 ganglioside   12-03-2012   Acute spinal cord injury

18

     prothrombin complex concentrate, a concentrate of human   coagulation factors II, VII, IX and X, and proteins C and S   12-27-2012   Need for urgent reversal of Vitamin K   antagonist therapy for treatment of major bleeding and/or surgical procedures

19

     recombinant human gowth hormone in an ocular delivery   system   12-03-2012   Persistent corneal epithelial defects

20

     recombinant human monoclonal antibody of the IgG1 kappa   class against prostate stem cell antigen   12-03-2012   Pancreatic cancer

21

     trans sodium crocetinate   12-03-2012   Brain metastasis

22

     vancomycin   12-27-2012   Endophthalmitis

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: