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US FDA panel gives a resounding yes to HRA Pharma's emergency contraceptive

This article was originally published in Scrip

Executive Summary

The US FDA's advisory committee on reproductive health drugs gave the strongest possible endorsement to the new drug application from HRA Pharma to market ulipristal acetate as an emergency contraceptive (EC) drug. The panel not only voted unanimously that the sponsor had proved the efficacy and safety of the drug, but also registered a 10-0 vote against the FDA suggestion that special measures might be needed to address potential off-label use of the medication."The data were compelling," explained committee member Dr Julia Johnson, chair of the ob/gyn department at the University of Massachusetts.

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