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US FDA extends review period of NDA for oral contraceptive Yaz

BerlinSaturday, December 10, 2005, 08:00 Hrs  [IST]

The US Food and Drug Administration has extended the review period of Schering AG’s US affiliate, Berlex Inc for the new drug application (NDA) regarding its new oral contraceptive Yaz containing 20 micrograms ethinyl estradiol and 3 milligrams drospirenone, in a unique, 24-day regimen. “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 gynaecology and andrology at Schering AG. According to a company release, a unique feature of Yaz is an innovative dosing regimen of 24 days of active pills followed by 4 days of placebo pills. In the United States, oral contraceptives typically contain 21 days of active pills with 7 days of placebo.

 
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