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collectBayerNews_20070129_0035_en.pdf BayerNews_20070129_0035_en.pdf
Berlin - Bayer Schering Pharma AG announced today that the U.S. Food and Drug
Administration (FDA) has approved a new indication for the company's oral
contraceptive YAZ® (3 mg drospirenone/20 mcg ethinyl estradiol), to treat
moderate acne in women who desire an oral contraceptive for birth control.
With this approval, YAZ becomes the first and only oral contraceptive ever
approved by the FDA for three distinct indications. YAZ received FDA approval
as an oral contraceptive in March, 2006, and as a treatment for the emotional
and physical symptoms of premenstrual dysphoric disorder (PMDD) in October,
2006. YAZ has demonstrated statistical and clinical significance in treating
mood swings, irritability, headaches, feeling anxious, bloating and food
cravings caused by PMDD that impact a woman's life.
"We are delighted to have received the approval for YAZ in this third
indication. Through its innovative active ingredient drospirenone, it offers
additional benefits to women who want reliable birth control," said Phil Smits,
Head of the Business Unit Womens' Healthcare at Bayer Schering Pharma. "YAZ is
the fastest growing oral contraceptive brand in the U.S. We are convinced that
through its unique features, YAZ will further strengthen our worldwide leading
market position in the field of female contraception."
Additional information
Two multicenter, double-blind, placebo-controlled, randomized clinical trials
of over 1000 patients revealed the statistically significant efficacy of YAZ in
treating acne. In the trials, treatment with YAZ resulted in significant
reductions in total lesion counts and in inflammatory/non-inflammatory lesion
counts. Further, investigator ratings of "clear" and "almost clear" skin as
rated on the Investigator's Static Global Assessment (ISGA) scale were nearly
four times greater in the YAZ treatment group than in the placebo group.
Bayer Health Care
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading,
innovative companies in the healthcare and medical products industry and is
based in Leverkusen, Germany. The company combines the global activities of the
Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. The
Pharmaceuticals division, Bayer Schering Pharma, comprises the following
business units: Women's Healthcare, Diagnostic Imaging, Specialized
Therapeutics, Hematology/Cardiology, Primary Care, and Oncology. Bayer
HealthCare's aim is to discover and manufacture products that will improve
human and animal health worldwide. The products enhance well-being and quality
of life by diagnosing, preventing and treating diseases.
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