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J Pediatr Pharmacol Ther. 2012 Oct;17(4):329-39. doi: 10.5863/1551-6776-17.4.329.

Recent new drug approvals. Part 1: drugs with pediatric indications.

Author information

  • 1Department of Clinical Pharmacy, University of Tennessee Health Science Center, Memphis, Tennessee ; Le Bonheur Children's Hospital, Memphis, Tennessee.

Abstract

This two-part review provides information about drugs that have been recently approved by the Food and Drug Administration and focuses on drugs approved with pediatric indications or approved in adults with active pediatric studies. Information was obtained from the product labeling and selected published studies. Part 1 reviews recently approved drugs with labeled pediatric indications, and Part 2 will review recent drug approvals in adults that have potential use in pediatrics and have active studies.

KEYWORDS:

Food and Drug Administration; drug approval; drug industry; pediatric

PMID:
23412997
PMCID:
PMC3567886
DOI:
10.5863/1551-6776-17.4.329
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