Navigation Links
FDA Approves Combination Contraceptive Containing a Folate
Date:9/24/2010

SILVER SPRING, Md., Sept. 24 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Beyaz tablets, an estrogen/progestin combined oral contraceptive that also contains a folate (levomefolate calcium 0.451 mg).

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

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

Levomefolate calcium is a metabolite of folic acid, a water-soluble B-vitamin that helps produce and maintain new cells in the body. A known association of low folate levels and neural tube defects (e.g., spina bifida) has resulted in recommendations that women of childbearing age supplement their diet with folate.

Beyaz is based on the approved product YAZ, which contains the same doses of estrogen and progestin, and is approved for:

  • Prevention of pregnancy
  • Treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive for contraception and
  • Treatment of moderate acne vulgaris in women at least 14 years of age, only if the patient desires an oral contraceptive for birth control.

In addition to the approved YAZ indications, Beyaz also is approved for the secondary indication in women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.

The primary efficacy study for Beyaz was a multicenter, double-blind, randomized, controlled U.S. trial in 379 healthy women age 18 to 40 who were treated with Beyaz or YAZ alone for up to 24 weeks. Beyaz was found to increase folate levels in women. In a German study of Beyaz, folate levels remained elevated for several weeks following discontinuation of Beyaz.  Safety and efficacy data for contraception, PMDD, and acne indications were obtained from previous YAZ clinical trials.

The most common side effects reported by users of combined oral contraceptives are irregular uterine bleeding, nausea, breast tenderness, and headaches. Other serious side effects include vascular events (blood clots) and liver disease.  Women over age 35 who smoke should not use this product as cigarette smoking increases further the risk of serious cardiovascular events.  The common adverse events for Beyaz are expected to be the same as those for YAZ.  There were no findings from the clinical trials with Beyaz to suggest a change in the overall safety profile compared to that of YAZ.

Beyaz is manufactured by Bayer HealthCare Pharmaceuticals Inc., the U.S.-based business arm of Bayer HealthCare LLC, a subsidiary of Bayer AG.

Approved Drugs: Questions and Answers http://www.fda.gov/Drugs/ResourcesForYou/Consumers/UCM054420

Contact: Elaine Gansz Bobo, 301-796-7567, elaine.bobo@fda.hhs.gov


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

Related medicine technology :

1. U.S. FDA Approves New Oral Contraceptive That Also Raises Folate Levels
2. FDA Approves NDA That Includes Psychiatric Data Collected by Centralized Raters
3. FDA Approves New Dosing for FASLODEX® (fulvestrant) Injection in Treatment of Metastatic Breast Cancer in HR+ Postmenopausal Women
4. FDA Approves Pediatric Use of Chemical Poisoning Treatment
5. FDA Approves Merz Pharmaceuticals Xeomin® (incobotulinumtoxinA) for the Treatment of Cervical Dystonia and Blepharospasm
6. FDA Approves Vaccines for the 2010-2011 Influenza Season
7. FDA Approves Strativa Pharmaceuticals Zuplenz® (ondansetron) Oral Soluble Film
8. FDA Approves Sagent Pharmaceuticals Heparin Sodium Injection, USP
9. U.S. FDA Approves Improved Performance of Riverain Medicals OnGuard Chest X-ray Computer-Aided Detection Technology
10. FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women
11. FDA Approves New Treatment for Late-Onset Pompe Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... 2016 Amgen (NASDAQ: AMGN ) will present ... Conference at 9:15 a.m. ET on Wednesday, Feb. 10, 2016, ... W. Meline , executive vice president and chief financial officer ... the presentation can be accessed from the Events Calendar on ... the webcast will also be available on Amgen,s website for ...
(Date:2/5/2016)... Feb. 5, 2016  ivWatch, a medical devices company, is ... Award granted by Governor Terry McAuliffe,s office. ivWatch ... February 25th at an event to be held at the ... award honors professionals and business that have made significant contributions ... Logo - http://photos.prnewswire.com/prnh/20160205/330117LOGO ...
(Date:2/5/2016)... MILTON, Ontario , Feb. 5, 2016  Aralez ... business combination of POZEN Inc. ("POZEN") and Tribute Pharmaceuticals Canada ... of POZEN and shareholders of Tribute. The combined company ... specialty pharmaceutical company with operations in Canada ... the United States . Under the terms ...
Breaking Medicine Technology:
(Date:2/5/2016)... Florida (PRWEB) , ... February 05, 2016 , ... Steven ... event he has completed every year since it started in 2003. This year, he ... the attention of fellow runners and NBA team the Miami Heat. , This Sunday, ...
(Date:2/5/2016)... ... February 05, 2016 , ... ... company's lighter, sleeker next generation LYNX VR Indoor Trainer with multi-rider capability to ... design and manufacturing not only reduce the weight of the unit, they also ...
(Date:2/5/2016)... ... 2016 , ... Successful recruitment and retention efforts, new collaborations ... have all marked the last 12 months at Roswell Park Cancer Institute (RPCI). ... oldest cancer center, Candace S. Johnson, PhD, outlined the many accomplishments of her ...
(Date:2/5/2016)... ... February 05, 2016 , ... The Muscular ... Louisiana Kitchen restaurants, launched the 14th annual “Appetite for a Cure” campaign on ... muscular dystrophy, ALS and related diseases that severely limit strength and mobility. ...
(Date:2/5/2016)... York, New York (PRWEB) , ... February 05, 2016 , ... ... life? The answer may be at the tips of your toes. Foot massage, whether ... as well as pure comfort and relaxation. The American Board of Multiple Specialties ...
Breaking Medicine News(10 mins):