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FDAnews Drug Daily Bulletin
June 21, 2010 | Vol. 7 No. 120
FDA Panel Recommends Approval of Emergency Contraceptive Ella
The FDA’s Reproductive Health Drugs Advisory Committee has recommended approving HRA Pharma’s emergency contraceptive Ella. The committee voted 11–0 Thursday that Ella (ulipristal acetate) was both safe and effective, saying that HRA provided sufficient information to conclude that the drug reduces the likelihood of pregnancy when taken within 120 hours (five days) after unprotected intercourse or contraceptive failure. Panel members also voted unanimously that there was no need for the FDA to impose measures beyond product labeling and healthcare provider education to address potential off-label use of the drug.
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