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Posts Tagged ‘ovulation’

Ella Approved by FDA

by admin on: October 10th, 2011

The U.S. Food and Drug Administration (FDA) approved the drug, ella??? (ulipristal acetate), which is a progesterone agonist/antagonist that can delay or inhibit ovulation. This drug may be used for emergency contraception and will prevent pregnancy when taken orally within five days (about 120 hours) after unprotected intercourse or a contraceptive failure. Ella is only available with a prescription and is not intended to be used as a contraceptive, nor is it to be used for terminating an existing pregnancy.

While this pharmacological product has been available in Europe since May of 2009, marketed under the name ellaOne, the FDA Advisory Committee for Reproductive Health Drugs did not evaluate this product until June of 2010. At that time, the committee unanimously voted to approve ella based on data that demonstrated the efficacy of this product, as well as providing sufficient information about the safety of this product for its proposed use as an emergency contraception product.

Regarding the safety and efficacy of ella, two Phase III clinical trials were conducted. One of these studies was a prospective, multicenter, single-arm, open-label trial that was conducted in the United States. The second trial was conducted in a randomized, multicenter, single-blind, comparator-controlled trial that was conducted in the United States, the United Kingdom and Ireland. The adverse effects that were most frequently reported in patientsinvolved in the clinical trialsincluded: abdominal pain (12%), dizziness (5%), pain and discomfort during menstruation (9%), fatigue (6%), headache (18%) and nausea (12%).

Some information included in ella’s product label: patients that take it should not concurrently take drugs or herbal products that evoke the actions of certain enzymes (for example, drugs or herbs that affect CYP3A4), as these products may decrease the effectiveness of ella. For more information regarding this pharmaceutical product, visit the FDA website, www.fda.gov.