Schering receives FDA approval for low-dose oral contraceptive YAZ

By E. Janene Geiss

Philadelphia, March 17 - Schering AG announced Friday that the Food and Drug Administration has approved the new low-dose, monophasic oral contraceptive YAZ (3 mg drospirenone/20 mcg ethinyl estradiol).

It is the first pill with the innovative progestin drospirenone and a low dose of ethinyl estradiol in a new dosing regimen of 24 days of active hormone pills and four days of a placebo, according to a company news release.

YAZ will be launched in the United States in April by Berlex, Inc., a U.S. affiliate of Schering, officials said.

"The YAZ approval is an important milestone for Schering. This significantly adds to the blockbuster potential of our Yasmin product family," Hubertus Erlen, chairman of the executive board, said in the release.

The company said it plans to file for approvals in Europe soon.

The YAZ regimen reduces typical monthly hormonal fluctuations compared to traditional oral contraceptives with regimens of 21 days of active pills and seven days of a placebo, officials said.

Schering said it continues to pursue FDA approval of YAZ for the treatment of emotional and physical symptoms of premenstrual dysphoric disorder (PMDD), which is a severe form of premenstrual symptoms (PMS) among women who desire contraception.

Like Yasmin, the No. 1 brand birth control pill worldwide, YAZ contains progestin drospirenone. Drospirenone exhibits antimineralocorticoid and antiandrogenic properties, unlike any other progestin available in oral contraceptives, company officials said.

Schering is a Berlin, Germany, research-based pharmaceutical company focused on gynecology and andrology, oncology, diagnostic imaging and specialized therapeutics for disabling diseases.

Berlex, a U.S. affiliate of Schering, is a Wayne, N.J., pharmaceutical company that researches and develops therapeutics in oncology, gastroenterology, women's health, diagnostics and neurology. Berlex also markets diagnostic imaging agents, treatments in the areas of female health care and oncology and specialized therapeutics for life-threatening and disabling diseases of the central nervous system and cardiovascular system.

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