Bayer Schering Pharma AG, Germany, announced today that the Dutch regulatory authorities have granted national approval for their new low dose 24-day oral contraceptive YAZ® (3 mg drospirenone/20 mcg ethinyl estradiol) in the Netherlands. YAZ® will be registered for the indications oral contraception and the treatment of moderate acne in women seeking contraception. The Netherlands will serve as the Reference Member State for the upcoming Mutual Recognition Procedure to gain European-wide marketing approval for the product.“We are very excited about this first European approval for YAZ®. YAZ® is the first oral contraceptive to combine the unique progestin drospirenone with 20 mcg of ethinyl estradiol in a 24-day active hormone pill regimen. Through its innovative active ingredient drospirenone, YAZ® offers additional benefits, such as the treatment of acne, to women who want reliable birth control,” said Phil Smits, M.D., Head of Women’s Healthcare at Bayer Schering Pharma AG.
YAZ®, which has been available in the U.S. since April 2006, is the fastest-growing oral contraceptive brand in the U.S. YAZ® is also the only oral contraceptive with clinically proven efficacy in the treatment of the emotional and physical symptoms associated with PMDD (Premenstrual Dysphoric Disorder), such as mood swings, irritability, anxiety, changes in appetite and eating habits, breast tenderness, bloating, and headache. YAZ® was granted this indication in the USA in October 2006. Bayer Schering Pharma AG plans to proceed with the application for the registration of the PMDD indication in Europe. With the approval for the treatment of acne in January 2007, YAZ® becomes the first and only oral contraceptive ever approved in the USA for three distinct indications.
About YAZ®
Like Yasmin®, the number one brand birth control pill worldwide, YAZ® contains the innovative progestin drospirenone. Drospirenone exhibits unique antimineralcorticoid and antiandrogenic properties, unlike any other progestin available in oral contraceptives. Due to drospirenone’s antiandrogenic action, YAZ® can be used for the treatment of acne, which is primarily caused by an increased production and/or activity of male sex hormones (androgens).
YAZ® has a new dosing regimen of 24 days of active hormone pills and four days of placebo. This innovative regimen combined with drospirenone’s benefits reduces typical monthly hormonal fluctuations compared to traditional oral contraceptives with intake regimens of 21 days of active pills and seven days of placebo.
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. 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 business operates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de
No comments:
Post a Comment