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FDA Orphan Drug Designations: 2013 11-Month Activity

December 3, 2013

Please Note: On 12/03/13, the November 2013 & Grand Totals are updated.

This is the first in a series of Blog Posts this week, on the review of the first eleven months of 2013 for orphan drugs. The first eleven 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 eleven months of 2012 versus the number of FDA ODDs of the first eleven months of 2013.

The chart below identifies the number of FDA ODDs for each month of 2012 and 2013, and the percent change in total activity. The FDA’s Orphan Drug Product Designation Database Application is used to generate the data :

Comparison of FDA Orphan Drug Designation Activity: 2012 vs 2013

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

21

133.3 %

September

24

43

79.2 %

October

13

28

115.4 %

November

14

23

64.3 %

Grand Totals

167

236

41.3 %

Here are a few observations:

•    Increase in the # of FDA ODDs every month from 2012 to 2013, except for February & July
•    September 2013 has the largest # of FDA ODDs of 43
•    Overall increase of approximately 41.3 % in the # of FDA ODDs for the first 11 months of 2013 compared to the first 11 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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