Schering granted extended review period by FDA for YAZ oral contraceptive

By Angela McDaniels

Seattle, Dec. 9 - Schering AG said the Food and Drug Administration has extended the review period of the Investigational New Drug Application for YAZ, an oral contraceptive, to the first quarter of 2006.

The application was submitted through U.S. affiliate Berlex Inc., the company said.

"We now expect a decision from the FDA in the first quarter of 2006. We are optimistic that YAZ will be available to women in the first half of 2006," said Phil Smits, head of gynecology and andrology at Schering AG, in a company news release.

YAZ contains 20 micrograms ethinyl estradiol and 3 milligrams drospirenone and has a unique, 24-day dosing regimen followed by four days of placebo pills.

In the United States, oral contraceptives typically contain 21 days of active pills with 7 days of placebo.

Schering AG is a pharmaceutical company based in Berlin. Its activities are focused on gynecology, andrology, oncology, diagnostic imaging and specialized therapeutics for disabling diseases.

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