FDA Approves Ella™ Tablets For Prescription Emergency Contraception : RushPRNews - Newswire & Global Press Release Distribution

 
Bookmark and Share

FDA Approves Ella™ Tablets For Prescription Emergency Contraception

August 16, 2010

FDA Approves Ella™ Tablets For Prescription Emergency Contraception
Washington, DC (rushPRnews) 08/16/10 — The U.S. Food and Drug Administration  approved ella™ (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.
 
ella is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation. Since May 2009, the prescription product has been available in Europe under the brand name ellaOne.
 
An FDA Advisory Committee for Reproductive Health Drugs discussed ella in June, 2010. The committee unanimously voted that the application for ella provided compelling data on efficacy and sufficient information on safety for the proposed indication of emergency contraception.
 
The safety and efficacy of ella were demonstrated in two Phase III clinical trials. One study was a prospective, multi-center, open-label, single-arm trial conducted in the United States;
FDA Approves Ella™ Tablets For Prescription Emergency Contraception
FDA
the other was a randomized, multi-center, single-blind comparator-controlled trial conducted in the United States, United Kingdom and Ireland.  
 
Side effects most frequently observed with ella in the clinical trials include: headache, nausea, abdominal pain, pain/discomfort during menstruation (dysmenorrhea), fatigue, and dizziness. The profile of side effects for ella is similar to that of FDA-approved levonorgestrel emergency contraceptives.
 
According to the product’s labeling, women with known or suspected pregnancy and women who are breastfeeding should not use ella. A patient package insert also will be provided to ensure that women are fully informed of the benefits and risks involved in the use of ella.
 
ella is manufactured by Paris-based Laboratoire HRA Pharma. ella will be distributed by Watson Pharma Inc., of Morristown, N.J.
 
For more information:
 

ella Labeling Information

Editors note: Approved trade name is lower case ‘e.’

Media Contact Name: Elaine Gansz Bobo
Media Phone: 301-796-7567
Company Phone: 888-INFO-FDA
Main image credits: HRA Pharma
Body image credits: FDA
About the author:

FDA is an agency within the Department of Health and Human Services and consists of seven centers and offices

Click here to see all news from this author/company

Filed Under: BREAKING NEWS, FDA- Pharmaceutical news, Health and Fitness, Lifestyle, PRESS RELEASE

RUSH PR NEWS newswire and press release services at rushprnews.com / AH Marketing ahmarketinggroup.com

Content- Legal Responsibility - All material is copyrighted - You may repost but you MUST link back to the original post on your page and acknowledge Rush PR News as the news source. Rush PR News is not legally and/or morally responsible for content of press releases, opinions expressed or fact-checking.

Rush PR News cannot be held legally responsible for material published and distributed through its newswire service or published in its press-room and therefore cannot be sued for published material. Third-party must be contacted directly to dispute content.

Rush PR News is not the contact for material published.

RSSFeed PRESS & SOCIAL MEDIA RELEASES

FlipBelt Launches Hydration Belt for Runners and Fitness Enthusiasts

DENVER, CO 06/22/16 · FlipBelt announces new version of its wildly popular...

Kickstarter Fun: Wu & Y: Combines Art & Activewear

Brooklyn, NY 06/16/16 · Artistic Activewear Brand Raises 20K on the First...

Nursing Schools Struggle to Keep Up With Demand for Nurses

Peoria, Illinois 06/15/16 · Recent studies carried out by the Georgetown Center...

20 Dollars Discount On All PR Distribution Packages Now

San Francisco 06/14/16 · Time to share the joy again! We just...

A Look Back at RPRNmag Newsmagazine Crowdfunding Stories

San Francisco 06/09/16 · CROWDFUNDING A Look Back at Crowdfunding Campaigns: From Wood...

RPRNmag Newsmagazine Top Stories in May: Robotics & Education

San Francisco 06/07/16 · Recap Stories for the Month of MayLooking back...

Top 5 Must-Have Technologies for Startup Businesses

San Francisco 06/07/16 · Find the Secret to Making Your Small Business...

Ultraseal explains the transformation of casting impregnation at conference in Mexico

Querétaro, Mexico 06/07/16 · The transformation of casting impregnation into a two-stage,...

Diligence International Knows Latin America

Carrollton, TX 06/03/16 · As global investigators, Diligence International Group, LLC (www.digroup-us.com)...

Losode Makes The Second Round at Voom2016

LONDON, UNITED KINGDOM 06/01/16 · Losode set to disrupt the global fashion industry...

$20 Off PR Events Coupon. Publish Your Press Release Today

San Francisco 05/31/16 · RushPRNews' motto is PR Made Easy, and we are...

High-Tech Bridge Uncovers Large Number Of Fraudulent Cybersecurity Company Domains

San Francisco, CA and Geneva Switzerland 05/27/16 · Research into the proliferation of fraudulent domains affecting...

Compliance Map tracks Country of Origin in complex supply chains

Oxfordshire, UK 05/26/16 ·  The Compliance Map, a developer of environmental compliance...