New Drug Approvals and New Pediatric Indications

An Update for Pediatric Healthcare Providers

Marcia L. Buck, PharmD, FCCP, FPPAG, BCPPS


Pediatr Pharm. 2017;23(7) 

In This Article

Abstract and Introduction


Several new drugs have been approved by the Food and Drug Administration (FDA) in the past 6 months that benefit pediatric patients. While most are new formulations of drugs previously in use, there are a few new drug entities. The FDA has also approved the inclusion of pediatric patients in the indications for use for more than a dozen drugs since the beginning of the year. These expanded indications typically follow the submission of pediatric studies by the manufacturer in order to qualify for a 6-month extension of their patent rights under the Pediatric Exclusivity Program. This program, a part of the FDA Modernization Act of 1997, has resulted in new labeling information for a total of 692 drugs as of May 31, 2017. A database of new pediatric labeling is available on the FDA website at