In the Pipeline: FDA Advisory Committee Reviews - June 2004

Jane S. Ricciuti, RPh, MS; Regina M. Ballinger, RN; Walter E. Chalkley

Disclosures

AdComm Bulletin. 2004;2(5) 

In This Article

Introduction

The US Food and Drug Administration (FDA) convenes public advisory committee meetings to address issues in new drug applications (NDAs), biologics license applications (BLAs), or clinical trials that are currently under FDA review. Although FDA advisory committees provide non-binding recommendations to the FDA, the FDA usually follows their recommendations.

The In the Pipeline column provides a summary of recently convened FDA advisory committee meetings. At press time these products may have not received a final decision from the FDA on the issues summarized in this column.

In June 2004, FDA advisory committee meetings convened to review the following topics currently under FDA review:

  • Oxyprim (oxypurinol)

  • Arcoxia (etoricoxib)

  • Congenital neonatal withdrawal syndrome from exposure in utero to selective serotonin reuptake inhibitors (SSRIs) and pediatric eye malformations related to antidepressants.

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