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:6/26/2016)... , June 27, 2016  VMS Rehab Systems, Inc. ... will take whatever measures required to build a strong ... which is currently listed on the OTC Markets-pink current ... Chairman and CEO, "We are seeing an anomaly in ... understand, not only by the Company, but shareholders and ...
(Date:6/24/2016)... June 24, 2016  Consumers have taken a ... have placed more emphasis on patient outcomes. ... programs in the pharmaceutical industry have evolved beyond ... pharmaceutical companies are focusing on becoming more patient-oriented ... products and services that improve health. ...
(Date:6/24/2016)... , June 24, 2016  Global Blood ... biopharmaceutical company developing novel therapeutics for the treatment ... today announced the closing of its previously announced ... stock, at the public offering price of $18.75 ... offering were offered by GBT. GBT estimates net ...
Breaking Medicine Technology:
(Date:6/25/2016)... Canada (PRWEB) , ... June 25, 2016 , ... Conventional ... pursuit of success. In terms of the latter, setting the bar too high can ... risk more than just slow progress toward their goal. , Research from ...
(Date:6/24/2016)... ... ... crisis. Her son James, eight, was out of control. Prone to extreme mood shifts and ... him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife on ... say he was going to kill them. If we were driving on the freeway, ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Comfort Keepers® of ... Cancer Society and the Road To Recovery® program to drive cancer patients to and ... other adults to ensure the highest quality of life and ongoing independence. Getting ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute Beauty ... Barry M. Weintraub as a prominent plastic surgeon and the network’s newest partner. ... and the most handsome men, look naturally attractive. Plastic surgery should be invisible.” ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) ... held on June 20th at the Woodmont Country Club at 1201 Rockville Pike, Rockville, ... dedicated to helping service members that have been wounded in battle and their families. ...
Breaking Medicine News(10 mins):