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FDA Orphan Drug Designations: 2013 9-Month Activity

October 7, 2013

This is the first in a series of Blog Posts this week, on the review of the first nine months of 2013 for orphan drugs. The first nine months of 2013 continues the celebration and success for orphan drug development that is achieved in 2012.

This Blog Post compares the number of FDA Orphan Drug Designations (ODDs) of the first nine months of 2012 versus the number of FDA ODDs of the first nine months of 2013.

The chart below identifies the number of FDA ODDs for each month of 2012 and 2013 using the FDA’s Orphan Drug Product Designation Database Application :

Month

# of 2012   FDA ODDs

# of   2013 FDA ODDs

% Change   From 2012   To 2013

January

8

23

187.5 %

February

16

6

62.5 % –

March

20

24

20 %

April

11

18

63.6 %

May

8

23

187.5 %

June

12

15

8.3 %

July

32

12

62.5 % –

August

9

20

122.2 %

September

24

42

75 %

Grand Totals

140

183

30.7   %

Here are a few observations:

•    Increase in the # of FDA ODDs every month from 2012 to 2013, except for February & July 2013
•    September 2013 had the largest # of FDA ODDs of 42
•    Overall increase of approximately 30.7 % in the # of FDA ODDs for the first 9 months of 2013 compared to the first 9 months of 2012.

Please Note: “Pathologist with Microscope” courtesy of Bill Branson (Photographer) from the National Cancer Institute (NCI). [Public domain in the US].

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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