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U.S. Department of Health and Human Services

Drugs

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Pediatric Exclusivity Granted

  

 Drugs to Which FDA has Granted Pediatric Exclusivity for
Pediatric Studies under Section 505A of the
Federal Food, Drug, and Cosmetic Act

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 = 216

Total Approved Active Moieties Granted Exclusivity = 190

Total Approved Drugs Granted Exclusivity = 199


Pediatric Exclusivity Determinations List
(PDF - 356KB)