Approved Active Moieties to which FDA has issued a Written Request for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act
NOTE: This list simply identifies approved active moieties to which FDA has issued a Written Request for pediatric studies since June 1998. If a product appears on this list, it does not imply that studies have been conducted or submitted to the Agency, nor does it mean that the studies described in the Written Request will be conducted. A sponsor is NOT required to perform pediatric studies in response to a Written Request. Conducting pediatric studies in response to a Written Request is voluntary. Upon occasion, information obtained by FDA subsequent to issuance of a Written Request causes FDA to rescind the Written Request. This list is not updated to indicate when a Written Request has been rescinded.
- April 2021 Approved Active Moiety (XLS - 77 KB)