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FDA Orphan Drug Designations: 2013 11-Month Approval Rate

December 3, 2013

This is the second in a series of Blog Posts this week on the review of the first eleven months of 2013 for orphan drugs.

The chart below compares the number of FDA Orphan Drug Designation (ODD) Marketing Approvals in the first 11 months of 2012 versus the number of FDA ODD Marketing Approvals in the first 11 months of 2013. The FDA’s Orphan Drug Product Designation Database Application is the source of the data.

Comparison of FDA Orphan Drug Designation Approval: 2012 vs 2013

# of Jan-Nov   2012     FDA ODD Approvals

# of Jan-Nov  2013   FDA   ODD Approvals

% Change From 2012 To     2013

16

25

56.3 %

Conclusion

There is approximately a 56 % increase in the # of FDA ODD Marketing Approvals in the first 11  months of 2013 compared to the # of FDA ODD Marketing Approvals in the first 11 months of 2012.

Please Note: “Erlenmeyer Flasks” From Argonne US National Lab  [Public domain in the US] | Wikimedia Commons.

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

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2 Comments
  1. Madam Ann-Teresa, lovely effort on your blog, I am a regulator reader of your posts. thanks

    • Dr. Crasto – Many thanks !! I as well have been following your Blogs, which does a great job of keeping everyone informed of global drug approvals and activities. Ann

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