USA: ‘Ella’ emergency contraceptive pill wins FDA approval

A next-generation emergency contraceptive pill that can prevent unwanted pregnancy up to five days after unprotected sex has gained final approval from the Food and Drug Administration, the Money Times reports.

Developed in government laboratories, Ella will be dispensed as a single dose. Women will need a prescription but could keep a supply at home. The pill prevents pregnancy from occurring when taken within 120 hours (5 days) of unprotected intercourse or contraceptive failure.

Watson Pharmaceuticals, Inc., of Morristown, N.J., will begin preparations to commercialise the novel type of emergency contraception pill from French pharmaceutical company HRA Pharma of Paris in the fourth quarter this year, under an exclusive distribution agreement, according to US tabloid reports.

Developed in government laboratories, Ella will be dispensed as a single dose and women will need a prescription but could keep a supply at home. The pill prevents pregnancy from occurring when taken within 120 hours (5 days) of unprotected intercourse or contraceptive failure.

Approved last year in Europe, Ella is now available in at least 22 countries under the brand name ellaOne. Formulated as a 30-mg tablet, the pill is a progesterone agonist/antagonist that inhibits or delays ovulation.

In June 2010, Ella was unanimously endorsed by the Reproductive Health Drugs Advisory Committee of the FDA, agreeing that the drug was safe and found no evidence it was capable of terminating an existing pregnancy. Ella was proved effective and safe in two phase 3 clinical trials.

On 13 August, the FDA granted approval for the marketing of the pill in the United States, where it will compete with Teva Pharmaceutical Industries Ltd.’s Plan B, the morning-after pill now available over the counter to women 17 and older. The Plan B pill is only effective in the first 72 hours, while Ella can be taken within 120 hours, or five days, of unprotected intercourse or failure of some other contraceptive method.

The FDA said that women who are pregnant, or suspect that they are pregnant, and those who are breastfeeding should not use this product.

‘As a pioneer and a leader in the field of emergency contraception, HRA Pharma is committed to providing women and their health care providers highly effective contraceptive options,’ said Erin Gainer, CEO of HRA Pharma. ‘Ella, an effective and well-tolerated new generation emergency contraceptive, fulfills a significant and previously unmet need in this field by reducing pregnancy risk up to five days after intercourse.’

5-day-after Ella contraceptive pill wins FDA approval. The Money Times, 14 August 2010

Also read:

Is Ella Birth Control or Abortion? By Sarah Elizabeth Richards. Slate, 17 August 2010

Ulipristal acetate versus levonorgestrel for emergency contraception. Abortion Review, 29 January 2010