Additional pediatric information is needed in labeling for more than a third of approved orphan drug indications relevant to the pediatric population, the FDA said in a report to Congress.
The report covers drugs approved for orphan indications between April 1999 and August 2018 — 548 approved indications in total. Of those, 348 indications were relevant to children and merited pediatric use information in their labeling. But the agency found that 127 indications weren’t fully labeled for pediatrics.
The 127 indications were related to 98 drugs approved for one indication and 19 approved for more than one. Approximately two thirds contained no pediatric information at all, while the rest had “some pediatric labeling,” the agency said.