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:8/4/2017)... 4, 2017 The search for test results ... physician/patient consult has long been the goal of healthcare ... focus of the largest meeting of lab professionals and ... market research firm Kalorama Information.  The firm said scores ... or related supplies and software were at the American ...
(Date:8/2/2017)... BENTON, Ky. , Aug. 2, 2017   Marshall County Hospital in ... team to proactively reduce the risk of hospital-acquired infections (HAIs). The new addition, Tru-D ... UVC light energy to kill deadly pathogens such as C. diff , MRSA, MERS, ... Tru-D SmartUVC ... Tru-D in action in a patient room ...
(Date:7/31/2017)...  Diplomat Pharmacy, Inc. (NYSE: DPLO), has been named one ... by Crain,s Detroit Business . The annual ... three-year revenue growth. This year,s edition measures growth from 2013 ... the complete list, visit crainsdetroit.com/awards/fast_50/2017 .  ... said Phil Hagerman , CEO and chairman of Diplomat. ...
Breaking Medicine Technology:
(Date:8/17/2017)... , ... August 17, 2017 , ... A recent report ... the biopharmaceutical industry in 2016 cited deficiencies in data integrity. The FDA outlines their ... 11 ruling. , Presented as part of the Beckman Coulter Life Sciences ...
(Date:8/16/2017)... Bethpage, NY (PRWEB) , ... August 16, 2017 , ... ... Kullen, Long Island’s original family-owned supermarket, has put together suggestions for enjoying the season ... new recipe or activity, everyone in the family can join in on the fun. ...
(Date:8/16/2017)... ... 16, 2017 , ... Blue Health Intelligence (BHI) announced today that ... Dr. Spiro brings over 30 years of clinical, healthcare IT, value-based care, and change ... solutions. , “I am thrilled to welcome Dr. Spiro to BHI,” said Swati ...
(Date:8/16/2017)... SEATTLE, Washington and CARTERSVILLE, Georgia (PRWEB) , ... August 16, 2017 ... ... list of the fastest growing companies in the U.S. for the second year in ... shown strong growth over the past three years. , “To be on the list ...
(Date:8/16/2017)... FL (PRWEB) , ... August 16, 2017 , ... ... standardized product data and images announced today that it was acquired by Advantage ... Industry’s solution for product information. IX-ONE’s members include the industry’s leading suppliers, brokers, ...
Breaking Medicine News(10 mins):