FDAnews Drug Daily Bulletin

SCHERING AG RECEIVES FDA APPROVAL FOR YAZ

March 27, 2006
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The FDA has approved Schering AG's new low-dose, monophasic oral contraceptive Yaz, the German company announced.

Yaz (3mg drospirenone/20 mcg ethinyl estradiol) 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 placebo, Schering AG said recently.

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 placebo.

Schering AG's U.S. affiliate Berlex will launch Yaz in the U.S. in April 2006.

"The Yaz approval is an important milestone for Schering. This significantly adds to the blockbuster potential of our Yasmin product family," said Hubertus Erlen, chairman of the executive board of Schering AG. "Yaz joins the most innovative oral contraceptive portfolio worldwide, and will certainly contribute to our near and long-term success," he said.