HOME >> BIOLOGY >> NEWS
FDA clears Berlex Laboratories Mirena (R), new form of long-acting contraception meets need for U.S. women

Montville, NJ, December 6, 2000 Berlex Laboratories, Inc., the U.S. subsidiary of Schering AG, Germany (NYSE: SHR), announced today that the U.S. Food and Drug Administration (FDA) approved MIRENA(R) (levonorgestrel-releasing intrauterine system), a convenient, innovative contraceptive that is as effective in preventing pregnancy as tubal ligation (better than 99 percent) and lasts for five years, or until removed.

Available for 10 years in Europe, MIRENA has been used by approximately two million women worldwide and will be available for the first time in the U.S. in the first quarter of 2001. "Women in European and Asian countries have used MIRENA successfully and safely." says Felicia Stewart, MD, Incoming Chair of the Association of Reproductive Health Professionals. "For many women in the U.S. there has been a limited choice in convenient, reliable and reversible long-acting contraception. MIRENAs availability gives these women a choice they need and deserve."

In addition to preventing pregnancy, MIRENA use may result in a change in bleeding patterns. In the first three to six months following insertion, there may be an increase in intermenstrual bleeding. After this, a womans period may become shorter and lighter. Some women experience an absence of menstrual bleeding after one year.

MIRENA does not contain estrogen. It delivers a low dose of the progestin levonorgestrel directly to the lining of the uterus. Studies suggest several mechanisms that prevent pregnancy: thickening of cervical mucus, which prevents the passage of sperm, inhibition of sperm mobility and inhibition of endometrial growth. Berlex will market MIRENA under a license from The Population Council, which initially developed the contraceptive.

"MIRENA is the first in a series of major new products that Berlex will bring to market, and its introduction marks the beginning of an expansion in the Berlex position in women's health," said Reinhard Franzen, Vice
'"/>

Contact: Julie Mandell
julie_mandell@berlex.com
973-487-2592
Porter Novelli
6-Dec-2000


Page: 1 2 3

Related biology news :

1. Wildland fires: After the smoke clears
2. FDA clears for market new diagnostic test for lupus
3. Berlex Laboratories announces FDA approval of YASMIN (R), new oral contraceptive with unique progestin
4. Jay Levy honored with 2004 Abbott Laboratories Award in Clinical and Diagnostic Immunology
5. Immunex And Wyeth-Ayerst Laboratories Advance Enbrel Into Phase II/III Clinical Trial For Chronic Heart Failure
6. Study finds two-thirds of unplanned pregnancies in women using contraception
7. Proteins that bind to sperm offer clues to male fertility and possible male contraception
8. Chemistry meets Biology
9. The American Society for Biochemistry and Molecular Biology meets in Boston
10. Experimental Biology 2004 meets in Washington, D.C. April 17-21
11. Experimental Biology 2003 meets in San Diego April 11-15

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/16/2019)... Austin, TX (PRWEB) , ... June 14, 2019 ... ... only three Americans invited to lecture at the fifth annual Neodent World Congress. ... Congress explored the innovative progress and latest advancements in the world of dentistry. ...
(Date:6/14/2019)... ... June 14, 2019 , ... Molecular diagnostics segment is ... be $8,760 million in 2019. Major segments that are expected to drive the ... broken out and forecasted as segments in Kalorama’s The World Molecular Diagnostics Market, ...
(Date:6/13/2019)... ... June 13, 2019 , ... Global ... exclusively serving the end-to-end clinical and ancillary supply chain management needs of large- ... medical research organizations, today announced it will sponsor a summer education program offered ...
Breaking Biology News(10 mins):
(Date:7/17/2019)... ... July 16, 2019 , ... ... for the development and manufacturing of Zolgensma® (onasemnogene abeparvovec-xioi), an AveXis gene ... a Novartis company, will have dedicated manufacturing space at the new, state-of-the-art ...
(Date:7/9/2019)... Iowa (PRWEB) , ... July 08, 2019 , ... Today, ... Moines, Iowa, the National Corn Growers Association (NCGA) announced the winners of ... to improve a product or process using field corn to produce biobased materials. , ...
(Date:6/26/2019)... ... ... Alice Branton today released research results from preclinical trials on the beneficial ... prove to be beneficial for treating Hypomagnesemia. , The preclinical trial shows:, ... , Over 142% increase in particle size , Over 3% ...
(Date:6/12/2019)... ... June 12, 2019 , ... ... testing instruments for the Pharmaceutical, Biotechnology, Medical Device and Food Packaging Industries, is ... signed. The agreement will grant exclusive rights for Zillion to represent LDA in ...
Breaking Biology Technology:
Cached News: