Navigation Links
FDA Advisory Committee Unanimously Recommends Approval of HRA Pharma's Ulipristal Acetate for Emergency Contraception
Date:6/17/2010

PARIS, June 17 /PRNewswire/ -- www.hra-pharma.com -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.

Note

ella® is the proposed registered trademark to be used in the United States.

About HRA Pharma

HRA Pharma is a privately-held European pharmaceutical company that designs products, devices and supporting services in niche areas of health and makes them available to doctors and patients worldwide. The company targets therapeutic gaps in the areas of reproductive health and endocrinology, and uses innovative marketing solutions and socially-conscious programs, such as contraception education in developing countries, to promote healthy management of drugs and diseases. A pioneer in emergency contraception, its product ellaOne® can be taken for up to five days after unprotected sexual intercourse and is the only product licensed in the European Union for this indication. Headquartered in Paris, France and with offices in Germany, Italy, Spain, France and the UK, HRA Pharma has built a strong network of R&D, manufacturing, distribution and NGO partners which enables it to satisfy critical patient needs and improve patient health in over 50 countries across the globe. Visit http://www.hra-pharma.com for more information.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc., is a leading global specialty pharmaceutical company.  The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health.  Watson has operations in many of the world's established and growing international markets.

In the U.S., the Watson brand portfolio includes RAPAFLO®, GELNIQUE®, TRELSTAR® and INFeD®.  In addition, Watson markets the following brands under co-promotion agreements: AndroGel®, with Solvay Pharmaceuticals, Inc., and Femring®, with Warner Chilcott Limited.  The Watson brand pipeline portfolio includes a number of products, including URACYST®, under development for cystitis, and four novel new contraceptives.  

For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.


'/>"/>
SOURCE HRA Pharma
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. AstraZeneca Comments on FDA Joint Advisory Committee Meeting on Post-Marketing Safety Studies for the Use of LABAs in Asthma
2. InterMune Announces Conference Call and Webcast to Discuss Outcome of FDA Advisory Committee
3. FDA Advisory Committee Recommends Approval of InterMunes Esbriet(R) (pirfenidone) for Idiopathic Pulmonary Fibrosis
4. InterMune Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Pirfenidone
5. American Heart Association/American College of Cardiology Joint Science Advisory: AHA/ACC Issue Advisory on Diabetes Drugs and Heart Risk
6. Caliper Life Sciences Forms Scientific Advisory Board for Next Generation Sequencing
7. Government Relations CEO Joins MedeFile Advisory Board
8. Frank Phillips, Paul Anderson and Federico Girardi Join SI-BONEs Medical Advisory Board
9. Oramed Pharmaceuticals Expands Scientific Advisory Board With the Appointment of John Amatruda, M.D.
10. Former Air Force Surgeon General Joins Integrated Medical Systems Advisory Board
11. InterMune to Participate in Pulmonary-Allergy Drugs Advisory Committee Meeting on March 9, 2010
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/18/2017)... , Feb. 17, 2017 Research and Markets has ... report to their offering. ... The report provides separate comprehensive analytics for the US, ... , Asia-Pacific , Latin America , ... period 2015 through 2022. Also, a six-year historic analysis is provided for ...
(Date:2/17/2017)... , Feb. 17, 2017 Arvinas LLC, ... drugs based on protein degradation, today announced the presentation ... (AR) PROTAC during a poster session at the American ... GU) in Orlando, FL. ... validate our platform and the potential of PROTACs to ...
(Date:2/17/2017)... , Feb. 17, 2017   Risperdal lawsuits involving ... allegedly associated with use of the atypical antipsychotic medication ... Court of Common Pleas, where the state,s ... program. According to a notice posted on the ... a meeting on March 9, 2017 at 11:00 a.m. ...
Breaking Medicine Technology:
(Date:2/17/2017)... ... 2017 , ... Pharmica Consulting attended CHI's 8th Annual SCOPE ... trial planning and management. Pharmica discussed the importance of effective project management, data ... by Pharmica’s booth were able to demo its cloud-based Resource Management Tool, ...
(Date:2/17/2017)... ... 17, 2017 , ... Like most hospitals across the nation, Onslow Memorial Hospital ... the Hospital Readmission Reduction Program (HRRP), the return of a patient to the hospital ... the nation. While many providers are struggling to leverage limited resources and technology, Onslow ...
(Date:2/17/2017)... Plantation, FL (PRWEB) , ... February 17, 2017 ... ... protection services and financial planning assistance to families and business owners in the ... the LifeNet 4 Families organization. , For more than 30 years, LifeNet ...
(Date:2/16/2017)... ... February 17, 2017 , ... Teaching nursing care of vulnerable children is ... ACE.P (pediatrics) is being created with the support of the Hearst Foundations. An initiative ... ACE.P will address what has been identified as a critical gap in preparing the ...
(Date:2/16/2017)... , ... February 16, 2017 , ... ... highly regarded orthopedic surgeon, Dr. Raj, to their network through his work at ... Chemistry from Dalhousie University, and his medical degree from Canada’s prestigious International Baccalaureate ...
Breaking Medicine News(10 mins):