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FDA staff back new emergency contraceptive

Ulipristal, an emergency contraceptive which can be used up to five days after intercourse, has received a favourable review from FDA staff

An emergency contraceptive pill that can be used up to five days after unprotected intercourse or contraceptive failure has received a favourable review from US Food and Drug Administration (FDA) staff members in advance of a meeting of outside advisors scheduled for later this week.

The drug, a selective progesterone receptor modulator called ulipristal, is made by the French company HRA Pharma and is licensed in the US to Watson Pharmaceuticals. Currently, the only emergency contraception pill on the US market is Barr Pharmaceuticals' Plan B (levonorgestrel), which must be taken within 12 hours after intercourse.

In documents prepared for the upcoming advisory meeting, a team of FDA staff members from the Division of Reproductive and Urologic Products in the Office of New Drugs indicated that ulipristal appears to be safe and effective based on data from clinical trials submitted in the New Drug Application.

The staffers noted that the drug commonly produced side effects such as nausea and abdominal pain, but that it did not appear to be linked to any unexpected adverse events. They also noted that sufficient data does not yet exist to determine what effect the drug might have on a foetus if it in fact failed to prevent pregnancy.

The Reproductive Health Drugs Advisory Committee will meet on June 17 to make a recommendation to the FDA about whether Watson's drug, which the company hopes to market under the tradename ella, should be granted approval. The product received marketing approval from the European Medicines Agency (EMA) in May 2009.

Watson is seeking approval for ella as a prescription-only product. Barr's Plan B was originally approved as a prescription drug in 1999, but was granted over-the-counter status five years later in spite of vocal opposition from some religious and conservative groups.

16th June 2010

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