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:5/24/2016)... Dutch surgeons have launched a ground-breaking medical app to help ... on a global scale. Medical professionals from Europe ... and the US have already signed up for the app, which ... secure environment. Education  "Imagine a doctor for ... surgeon at Harvard to treat a bomb victim via live streaming ...
(Date:5/23/2016)... 23, 2016 Diplomat Pharmacy, Inc. (NYSE: DPLO) announced ... Internship programs. The hands-on learning experience is a 12-week ... paid Fellowship and Internship programs ... Fellows and interns are provided optional housing free of ... at the Riverfront Residence Hall to foster communication ...
(Date:5/23/2016)... 23, 2016 The World Health Organization (WHO) expanded ... to include adolescents aged 13 years, and above. Effective immediately, ... for adult and adolescent males in the 14 priority countries ... was the first male circumcision device to receive WHO Prequalification ... Eddy Horowitz said: " The expanded use ...
Breaking Medicine Technology:
(Date:5/25/2016)... ... , ... Today Omega Institute, a leading destination for yoga education in New ... in the growing field of yoga therapy . Yoga therapy adapts the ... health issues—including injuries, illnesses, and temporary or chronic health conditions. , “Yoga therapy is ...
(Date:5/25/2016)... ... 25, 2016 , ... The Global Wellness Summit (GWS) today announced that its ... of Europe, a continent that pioneered the medical/wellness concept for the world. , Delegates ... medical wellness, including Henri Chenot, Founder of the Chenot Group, which operates wellness centers ...
(Date:5/25/2016)... (PRWEB) , ... May 25, 2016 , ... ... the results of its annual Medical and Prescription Drug survey , an ... , The survey, which was conducted in December 2015, indicates that employers ...
(Date:5/25/2016)... , ... May 25, 2016 , ... Laser Skin ... help turn back the hands of time of female aging. The Juliet™ ... Women with symptoms such as leakage, laxity, itchiness and pain have reported real ...
(Date:5/25/2016)... ND (PRWEB) , ... May 25, 2016 , ... Consumer ... easier. In early June 2016, Kashi®, a maker of whole grain cereals and other ... a Certified Transitional ingredient: hard red winter wheat processed by Hesco/Dakota Organic Products. ...
Breaking Medicine News(10 mins):