FDA December 2013 Products Receiving Orphan Designation

Orphan Druganaut Blog

Please note: Updated 01/02/14 with 12/31/13 FDA Updates.

The chart below identifies FDA December 2013 Products Receiving Orphan Designation as of 01/02/14 in ascending “Designation Date” order.

Some Observations

•   21 products receive orphan designation in December 2013 (as of 01/02/14)

•   2 products receive orphan designation for Multiple Myeloma

•   Canakinumab receives orphan designation for 2 indications

•   20 % of the orphan designations are for an oncology indication.

FDA December 2013 Products Receiving Orphan Designation

Num

Generic Name Designation Date Orphan Designation

1

                                                                      Canakinumab 12-05-2013 Familial Mediterranean Fever

2

     Canakinumab 12-05-2013 Hyperimmunoglobulinemia D

and

Periodic Fever Syndrome

3

     Sotatercept 12-05-2013 Beta-Thalassemia Intermedia

and Major

4

     O2-(2,4-dinitrophenyl)   1-[(4-ethoxycarbonyl)piperazin-1yl]diazen-1-ium-1,2-diolate 12-13-2013 Multiple Myeloma

5

     Marizomib   12-13-2013 Multiple Myeloma

6

     Human…

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