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Watson launches ella in US

Following approval by the US Food and Drug Administration (FDA), Watson Pharma is to launch the emergency contraceptive, ella (ulipristal acetate), in the US

Watson Pharma is to launch the emergency contraceptve, ella (ulipristal acetate), in the US. The announcement comes after the US Food and Drug Administration (FDA) approved the drug as safe and effective in preventing unintended pregnancy for up to 120 hours - or five days - post-unprotected intercourse (UPI) or contraceptive failure.

Ella was developed by HRA Pharma and will be marketed in the US by Watson under an exclusive distribution agreement.

Ella is a progesterone agonist/antagonist emergency contraceptive to help prevent pregnancies at various stages of the menstrual cycle, including just before ovulation - the point in a woman's cycle when the probability of pregnancy is highest. Ella is effective in delaying ovulation for up to five days – the length of time sperm can survive in the genital tract.

Ella's 120-hour effectiveness time gives it the edge over currently available over-the-counter (OTC) levonorgestrel-based emergency contraception as these products are only effective for up to 72 hours and their effectiveness decreases just prior to ovulation. 

"Ella is an important new contraceptive option for US women, and its unique efficacy profile will give women an additional therapeutic alternative for preventing unintended pregnancy," said Fred Wilkinson, executive vice president, global brands at Watson.

"Beginning later this year, Watson will be offering women a novel emergency contraceptive that represents a logical, therapeutic complement to NextChoice, our generic levonorgestrel-based emergency contraceptive."

Ella will go on the US market in Q4 of this year and will only be available by prescription. Ulipristal acetate has been available in Europe since October 2009, where it is marketed by HRA Pharma as EllaOne.

16th August 2010


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