Premenstrual Dysphoric Disorder

Approvable letter granted for oral contraceptive containing drospirenone

Published in Women's Health Weekly, December 16th, 2004

The U.S. Food and Drug Administration (FDA) has issued an approvable letter to Berlex, Inc., a U.S. affiliate of Schering AG, Germany (SHR; SCH), for its new oral contraceptive containing 20 mcg ethinyl estradiol and 3 mg drospirenone (drsp), called YAZ.

The FDA has requested additional data to support this pill's unique dosing regimen-24 days of active pills followed by 4 days of placebo (inactive) pills. Oral contraceptives typically have a regimen of 21 days of active pills and 7 days of placebo.

In response to this letter, Berlex will submit data to support the clinical benefits of the additional three days of active pills in each cycle. The...

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Source: Women's Health Weekly (2004-12-16)

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