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 = 345 Total Approved Active Moieties Granted Exclusivity = 312 Total Approved Drugs Granted Exclusivity = 327 Pediatric Exclusivity Determinations List December 2025 (XLSX - 40 KB)