HRA Pharma announced today that the U.S. Food and Drug Administration's (FDA) Advisory Committee for Reproductive Health Drugs voted 11 to 0 that the company's application provided sufficient information to conclude that ulipristal acetate is effective and safe for use as an emergency contraceptive.
The committee's vote followed a review of data from the ulipristal acetate preclinical and clinical development program. Involving more than 4000 women from the U.S. and Europe, it is the largest development program ever conducted in the emergency contraceptive field.
"HRA Pharma is pleased with the outcome of the Advisory Committee's votes on the safety and effectiveness of ulipristal acetate," said Erin Gainer, CEO of HRA Pharma. "We look forward to working with the FDA to obtain approval for this new drug and offering a next-generation emergency contraceptive to women in the U.S."
The FDA is currently reviewing HRA Pharma's New Drug Application (NDA) for ulipristal acetate. While today's vote may be considered, the Agency is not bound by the recommendations of its advisory committees.
Ulipristal acetate was approved in May 2009 by the European Commission for marketing as an emergency contraceptive within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure. The product was launched in October 2009 and is marketed today in 22 European countries under the brand name ellaOne®.
As serving needs in reproductive health is a priority for HRA Pharma, the company plans to seek marketing approvals in countries worldwide. In the U.S., HRA Pharma submitted an NDA with the FDA in late 2009, and has entered into a licensing agreement with Watson Pharmaceuticals to commercialize this novel next-generation emergency contraceptive.
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