Pediatric Updates From the Food and Drug Administration

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


Pediatr Pharm. 2019;25(4) 

In This Article

Abstract and Introduction


The Food and Drug Administration (FDA) approved 25 novel drugs and biologics in 2018 and another 21 in the first quarter of 2019. While monoclonal antibodies and biosimilars continue to dominate the new approvals, a wide range of drugs have been introduced in the United States during this time. Several of these products carry a pediatric indication, but the majority are currently only approved for use in adults. Many of these drugs have the potential to be of benefit in the pediatric patient population and may eventually receive pediatric labeling. This issue of the newsletter will review these new treatment options, as well as granted new pediatric indications and drugs currently under FDA review.