The US Food and Drug Administration (FDA) approved the ella (ulipristal acetate) emergency contraceptive pill last week. This pill prevents pregnancy if taken within five days of unprotected intercourse or contraceptive failure.

This drug has been available in Europe since May 2009 and is a progesterone agonist/antagonist which is believed to work by inhibiting or delaying ovulation as per a statement issued by the FDA. It is a prescription-only drug.

The approval followed the unanimously supported approval of ella by an agency advisory committee in a decision which was announced in June.

The FDA noted, “The safety and efficacy of ella were demonstrated in two phase [3] clinical trials. One study was a prospective, multi-center, open-label, single-arm trial conducted in the United States; the other was a randomized, multi-center, single-blind comparator-controlled trial conducted in the United States, United Kingdom and Ireland.”

The side effects of ella have been noted to be similar to those of other emergency contraceptives which are already approved. The side effects could include headache, abdominal pain, nausea, pain/discomfort during menstruation, fatigue and dizziness.

The drug is not recommended for women who are pregnant or think that they might be pregnant or for nursing mothers.

The drug is manufactured by Paris-based Laboratoire HRA Pharma.