WAYNE, N.J., March 17 (UPI) -- Berlex said Friday the Food and Drug Administration approved its oral contraceptive Yaz, with rollout set for April.
Yaz is the first pill to include the progestin drospirenone in a 24-day regimen. Berlex, an affiliate of Schering AG, said the 24-day cycle will result in less hormonal fluctuation than oral contraceptives that utilize 21-day regimens.
"Yaz represents a clear advancement in oral contraception, and underscores the Berlex commitment to provide novel and innovative options in birth control to allow for individual choice," said Reinhard Franzen, Berlex's president and chief executive officer.
"We are continuing our dialogue with the FDA in order to take Yaz even further by bringing women the first oral contraceptive for the treatment of the emotional and physical symptoms of premenstrual dysphoric disorder," Franzen added.
The Yaz approval was supported by a trial involving 1,027 women that demonstrated safety and 99-percent contraceptive efficacy, Berlex said.
The drug's most common side effects were similar to other oral contraceptives and included upper respiratory infection, breast pain, yeast infection and vaginal discharge.
