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 (RPRN) 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 E-mail:
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 / Anne Howard annehowardpublicist.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

yWorld a New Vancouver Based Tech Company Launches Innovative Digital Conferencing Platform

Vancouver, B.C. 07/30/14 · Vancouver-based yWorld is pleased to announce that they...

Ste. Anne's Spa Nominated for Favourite Wellness Property in Canada

GRAFTON, ONTARIO 07/29/14 · Spafinder Wellness 365™ announced that Ste. Anne's Spa...

The new language exchange app is here! As easy as learning Chinese!

SAN FRANCISCO 07/23/14 · The new language exchange app ‘Social Language’ is now...

Xpressivo live on KickStarter! Get a Jolt!

SAN FRANCISCO 07/23/14 · Xpressivo: Start It Up!   Get a jolt today! Xpressivo’s new...

What’s better than distributing your press release to tons of outlets? Guaranteed AP Media Coverage!

San Francisco/Montreal/London 07/23/14 · Distributing your press release with GUARANTEED placement in...

Xpressivo: Bringing Coffee Back

SAN FRANCISCO 07/17/14 · Espresso drinkers – get excited! Now even the most...

Designz23 presenta SEO, avisos Google, Pago Por Click, sitios aptos para móviles

Allentown Y Bethlehem, PA 07/16/14 · – Designz23.com se complace en ofrecer lo último...

Remapping and Insurance: What You Need to Know

LONDON, UK 07/14/14 · With turbodiesels often getting some of the very...

Are Canadian consumers getting fleeced by the life insurance industry?

Halifax, NS 07/08/14 · Consumers have had enough and they want to...

Open Casting Call for W Network’s New Reno Competition Series Game of Homes

VANCOUVER, B.C. 07/08/14 · Casting underway in Vancouver W Network and Great Pacific Television are looking...

Vegan Recipe Cookbook Celebrates 70 years of Vegan

London, UK 07/08/14 · London based health and nutrition consultancy Foods for...

Discover the Benefits of Grand Estates Auction to the Buyer

Charlotte, NC 07/07/14 · Benefits of Grand Estates Auction to the Buyer...

Why Are Brokers considering Grand Estates Auctions? Discover the benefits

Charlotte, NC 07/06/14 · The Benefit of Grand Estates Auction to the...

Grand Estates Auction Company presents Music City Glamour

Nashville, TN 07/05/14 · Redisvoer Music City Glamour: Nashville, Tennessee Nashville is more...