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FDA Orphan Drug Approvals: 2011 And 2012 By The Numbers

March 2, 2013

In the FDA 2012 Report titled, “FY 2012 (10/01/11 – 09/30/12) Innovative Drug Approvals”, the following are the statistics for orphan drugs :

  1. FDA approves 35 New Molecular Entities (NMEs) in its fiscal year 2012
  2. Of the 35 NMEs for 2012, 9 or approximately 26% are for orphan drugs
  3. In the last 5 years, approximately 33% of the NMEs are for rare diseases
  4. 7 of the 9 or approximately 78% of the orphan drugs are “approved in the 1st cycle”
  5. 8 of the 9 or approximately 89% of the orphan drugs had their PDUFA dates met
  6. 6 of the 9 or approximately 67% of the orphan drugs were 1st approved in the US.

In the FDA 2011 Report titled, “FY 2011 (10/01/10 – 09/30/11) Innovative Drug Approvals”, the following are the statistics for orphan drugs :

  1. FDA approves 35 New Molecular Entities (NMEs) in its fiscal year 2011
  2. Of the 35 NMEs for 2011, 10 or approximately 29% are for orphan drugs
  3. In the last 5 years, approximately 30% of the NMEs are for rare diseases
  4. 6 of the 10 or approximately 60% of the orphan drugs are “approved in the 1st cycle”
  5. 10 of the 10 or approximately 100% of the orphan drugs had their PDUFA dates met
  6. 7 of the 10 or approximately 70% of the orphan drugs were 1st approved in the US.

Please Note:Pascal Triangle Animated” GIF by Hersfold on the English Wikipedia (Template:Bill) [GFDL or CC-BY-SA-3.0-2.5-2.0-1.0 | Wikimedia Commons.

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