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FDA January 2014 Products Receiving Orphan Designation

February 4, 2014

The chart below identifies FDA January 2014 Products Receiving Orphan Designation as of 02/04/14 in ascending “Designation Date” order.

Some Observations

•   17 products receive orphan designation in January 2014 (as of 02/04/14)

•   1 product receives orphan designation for Amyotrophic Lateral Sclerosis

•   1 product receives orphan designation for rare disease Friedreich’s Ataxia

•   Alexion Pharmaceutials receives another orphan designation for Eculizumab.

Row Num

Generic Name

Designation Date

Orphan   Designation

1

                                                                      eculizumab 01-10-2014 Prevention of delayed graft function after renal   transplantation

2

     enchochleate   amphotericin B 01-10-2014 Visceral Leishmaniasis

3

     factor   VIII mimetic bispecific antibody 01-10-2014 Hemophilia  A

4

                                                               human   allogeneic bone marrow derived osteoblastic cells
01-10-2014 Osteonecrosis

5

     rsATP7A   cDNA 01-10-2014 Menkes Disease

6

     monoclonal   antibody Hu3F8 01-10-2014 Osteosarcoma

7

     Allogeneic   motor neuron progenitor cells derived from human embryonic stem cells 01-17-2014 Amyotrophic Lateral Sclerosis

8

     ethanolamine   01-17-2014 Pediatric patients  with esophageal varices that are at risk of   bleeding to obliterate varices

9

     paquinimod 01-17-2014 Systemic Sclerosis

10

     tetra   substituted prophyrin derivative containing manganese (III) 01-17-2014 Radiation Exposure after nuclear accident/detonation

11

     flubendazole 01-23-2014 Lymphatic Filariasis

12

     vatiquinone 01-31-2014 Friedreich’s Ataxia

13

     NorLeu3-Angiotensin(1-7)   [NorLeu3-A(1-7)] 01-31-2014 Dermal injury due to nuclear/radiation incident

14

     Autologous   T Cells transduced with lentiviral vector containing a chimeric antigen   receptor directed against CD19 01-31-2014 Acute Lymphoblastic Leukemia

15

     recombinant   DNA plasmid 01-31-2014 Stage IIb, IIc, III and IV melanoma.

16

     brentuximab   vedotin 01-31-2014 Diffuse large B-cell lymphoma.

17

     cobimetinib 01-31-2014 Stage IIb, IIc, III, and IV melanoma with BRAFV600E   mutation.

.

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

Please Note: “Two small test tubes held in spring clamps” courtesy of  Amitchell125 at English Wikipedia [CC-BY-SA-3.0] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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