Navigation Links
FDA Approves New Combination Product Oral Contraceptive
Date:5/6/2010

SILVER SPRING, Md., May 6 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Natazia, a combination hormonal tablet for use as an oral contraceptive.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

Natazia contains two female hormones, an estrogen (estradiol valerate) and a progestin (dienogest), and is the first four-phasic oral contraceptive marketed in the United States. Four-phasic refers to the doses of progestin and estrogen varying at four times throughout each 28-day treatment cycle.

"Nearly 12 million women in the United States and more than 100 million women worldwide currently use oral contraceptives," said Scott Monroe, M.D., director of FDA's Division of Reproductive and Urologic Products. "The approval of Natazia provides another option for women who choose to use an oral contraceptive as their method of contraception."

The safety and efficacy of Natazia as an oral contraceptive was evaluated in two multicenter phase 3 clinical trials in North America and Europe. The trials involved 1,867 women and nearly 30,000 28-day treatment cycles.  Natazia was found to be effective as a hormonal contraceptive in both studies.  

The most common side effects observed with Natazia include irregular bleeding, breast tenderness, headaches, nausea and vomiting, increased weight, and acne.  Women older than 35 who smoke should not use this product. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use.  

Natazia is manufactured by Bayer HealthCare Pharmaceuticals of Wayne, N.J.

Media Inquiries: Elaine Gansz Bobo, 301.796.7567, elaine.bobo@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Labeling Change for Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII to Include Supplemental Data Demonstrating Significant Efficacy at Two Hours Through 14 Hours After Administration in Adults with ADHD
2. FDA Approves PROVENGE(R) for the Treatment of Men with Advanced Prostate Cancer
3. FDA Approves New Device for Adults with Severe and Persistent Asthma
4. FDA Approves Drug to Treat Condition That Causes Elevated Ammonia Levels
5. FDA Approves First of Its Kind, Fully Implantable (Surgically), Invisible, Prosthetic Hearing Restoration Device
6. FDA Approves First Totally Implanted Hearing System
7. FDA Approves Watsons TRELSTAR(R) 22.5 mg, the First and Only 6-Month Intramuscular GnRH Agonist for the Palliative Treatment of Advanced Prostate Cancer
8. FDA Approves Name Change for Heartburn Drug Kapidex
9. FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland
10. FDA Approves First New Inhaled Antibiotic for CF in More Than a Decade
11. FDA Approves Once-Daily MIRAPEX ER for the Treatment of Early Parkinsons Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... SAN DIEGO , Oct. 12, 2017   Divoti ... Medical Alert Jewelry up to the standard of the latest FDA ... (Launched: June 2017). Anyone in need of Medical ID ... Divoti Medical Alert Jewelry are engraved in terms of the ... ...
(Date:10/11/2017)... , Oct. 11, 2017  Hill-Rom Holdings, Inc. ... Aspen Surgical facility in Las Piedras, Puerto ... scalpels and blades. ... that the facility sustained minor structural damage, temporary loss ... Maria. Repairs have been completed, manufacturing operations have resumed, ...
(Date:10/4/2017)... 2017  South Korean-based healthcare product Development Company I.M. ... on Kickstarter. The device will educate the user about ... better efficiency compared to the dated and pricey CPR ... efficacy of the compression for a more informed CPR ... to raise $5,000. ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... “The Journey: From the Mountains to the Mission Field”: the story of a ... “The Journey: From the Mountains to the Mission Field” is the creation of published ... all ages and currently teaches a class of ladies at her church, which she ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the ... today its plans to open a flagship location in Covington, LA at 401 N. ... To Go store next to Office Depot in the Holiday Square shopping center. Its ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... AccentCare, a leader in post-acute health care, have expanded their existing home health ... Home Health. , AccentCare has been operating a joint venture home health company ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at ... for the 49th Congress of the International Society of Paediatric Oncology (SIOP) ... Center for Cancer and Blood Disorders at Children’s National, and Stephen P. ...
(Date:10/12/2017)... ... October 12, 2017 , ... In the ... a year. In some states—like New York, New Jersey, Massachusetts, Texas, Virginia, Connecticut, ... retirement havens have extremely low property-tax rates, which contributes to the relatively lower ...
Breaking Medicine News(10 mins):