New Drug Approvals and Safety Warnings Affecting Children

Marcia L. Buck, Pharm.D., FCCP, FPPAG


Pediatr Pharm. 2010;16(2) 

In This Article

Abstract and Introduction


More than sixty new drugs or drug formulations were approved by the Food and Drug Administration (FDA) during the past year. Among them were several agents targeted at pediatric disease states. Others not currently approved for pediatric use may still have a role in the off-label treatment of children with serious or refractory illnesses. During the last year, the FDA also made several important labeling changes for drugs already on the market to include pediatric indications or add new safety data. This issue of Pediatric Pharmacotherapy will review these new drugs and labeling changes and their potential impact on pediatric health care.


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