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Pediatric Exclusivity Granted

Posted Dec 02 2010 8:45am

NOTE: This list simply identifies approved active drugs with sponsors to which FDA has granted exclusivity for pediatric studies. Only applications held by the identified sponsor were granted pediatric exclusivity. This page is updated each time a drug has been granted pediatric exclusivity.

Total Exclusivity Determinations = 190   

Total Approved Active Moieties Granted Exclusivity = 167 

Total Approved Drugs Granted Exclusivity = 176


  Pediatric Exclusivity Determinations List (PDF - 185KB)  

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