Press Office
Food and Drug Administration
U.S. Department of Health and Human Services


NOTE TO CORRESPONDENTS          Print Media:         301-827-6242
March 25, 1998                  
                                Consumer Inquiries:  800-532-4440

DRAFT LIST PUBLISHED OF DRUGS NEEDING PEDIATRIC DATA

In an effort to garner information about how marketed drugs may be used with approved indications that could possibly help children, FDA has published a draft list of those drugs which would most benefit from this type of pediatric data.

The list, published on FDA's Internet home page, is a result of the 1997 FDA Modernization Act (FDAMA), which requires FDA to consult with experts in pediatric research to develop, prioritize and publish a list of approved drugs "for which additional pediatric information may produce health benefits in the pediatric population."

Drugs on the list had to meet one of the following criteria: (1) the drug product represents an improvement over standard therapy for children; (2) the drug is prescribed at least 50,000 times per year; (3) the drug is in a class or for a use where additional therapeutic options for children are needed.

FDA consulted with pediatric experts to develop the draft criteria and draft list of approximately 400 drugs, which may be examined at FDA's Dockets Management Branch or on the internet at http://www.fda.gov/cder/pediatric/. A final list is to publish on or before May 20, and FDA will be updating the list regularly.

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