Pediatric Exclusivity Granted
Drugs to Which FDA has Granted Pediatric Exclusivity for 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.
Pediatric Studies under Section 505A of the
Federal Food, Drug, and Cosmetic Act
Total Exclusivity Determinations = 209
Total Approved Active Moieties Granted Exclusivity = 183
Total Approved Drugs Granted Exclusivity = 192
Pediatric Exclusivity Determinations List (PDF - 117KB)