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U.S. Department of Health and Human Services


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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 = 219

Total Approved Active Moieties Granted Exclusivity = 193

Total Approved Drugs Granted Exclusivity = 202

Pediatric Exclusivity Determinations List
(PDF - 170KB)