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

Ultraseal International expands thanks to export success

Ann Arbor, MI 04/23/14 · Ultraseal International, the global leader in solutions to...

Kaigai Lifestyle Properties Announces Addition of a Brazilian Development to its Portfolio

Oakville, ON 04/22/14 · – International real estate advisors, Kaigai Lifestyle Properties,...

The Environmental Impact of Creek Excavation: Where Science and Nature Meet

London, United Kingdom 04/21/14 · Excavation is one of the most important and...

DEA HOLDS ITS EIGHTH PRESCRIPTION DRUG TAKE BACK DAY ON SATURDAY APRIL 26

Washington, D.C. 04/21/14 · -- After collecting more than 1,700 tons of expired,...

3 M's - Making Manners Matter

Windsor, Ontario 04/19/14 · 3 M's Making Manners Matter Getting people to improve...

VHL Developments to Start Phase 2 of 2150Condos Project

Toronto, ON 04/19/14 · VHL Developments is pleased to announce they will...

Zatun Game Studio Releases a List of Tools That Aid in iPhone Development

Ahmedabad, Gujarat, India 04/18/14 · Zatun Game Studio, a leading cross-platform video game...

Miami Boom Signals First Rating Increase Since 2004: Muni Credit

Miami, Florida 04/18/14 · Record demand from international investors is boosting prices...

Canadian actor/producer Corey Large presents the drug drama ‘Kid Cannabis’ out April 18

Los Angeles/Vancouver 04/14/14 ·  For Canadian actor/producer Corey Large, the drug drama...

Newborn Foundation Presents at 13th Design of Medical Devices Conference on Innovation for Developing Nations

MINNEAPOLIS, MN 04/10/14 · - Newborn Foundation co-founder and chairman Annamarie Saarinen...

Uk firms can succeed at exporting, says Ultraseal International

Ann Arbor, MI 04/09/14 · Understanding markets overseas is the key to exporting...

First App Created for General Public by Academy's Sci-Tech Council

Beverly Hills, Calif. 04/07/14 · ACADEMY COLOR PREDICTOR LAUNCHES ON iTUNES –The Academy Color...

Grand Estates Auctions sells highest priced home in five years in Pasco County, Florida.

Charlotte, North Carolina 04/04/14 · Sale achieved at auction sets a new benchmark...