FDA approves Watson, HRA Pharma’s emergency contraceptive
Watson Pharmaceuticals announced that the FDA approved ella (ulipristal) as an emergency contraceptive for use up to 120 hours following unprotected sexual intercourse or contraceptive failure. Watson, which entered into an exclusive distribution agreement with partner HRA Pharma over the drug, said it intends to launch ella, by prescription only, in the US in the fourth quarter.
The decision, which follows a positive review from an FDA panel, was based on two Phase III clinical trials which demonstrated "compelling data on efficacy and sufficient information on safety for the proposed indication of emergency contraception," the agency said. Anti-abortion groups had urged the FDA to reject the drug, noting that it is chemically similar to RU-486, but in the review, the panel said that it found no evidence the drug could terminate an existing pregnancy.
The drug garnered approval in Europe in May 2009, where it is sold under the brand name ellaOne.