Development Resources > Pediatric Exclusivity Granted

ediatric 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 = 190

Total Approved Active Moieties Granted Exclusivity = 167

Total Approved Drugs Granted Exclusivity = 176
Development Resources > Pediatric Exclusivity Granted


Pediatric Exclusivity Determinations List (PDF - 185KB)
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM223058.pdf