Schering's Contraceptive YAZ Receives 'Approvable Letter' From FDA, Pending Review Of Recent Data

Schering on Wednesday announced that it received an "approvable letter" from FDA for its oral contraceptive pill YAZ to treat premenstrual dysphoric disorder, a severe form of premenstrual syndrome, on the condition that the agency positively review recently submitted data on the drug's efficacy, Reuters reports (Reuters, 1/25). YAZ, which is manufactured by the Schering subsidiary Berlex, is a low-dose version of Schering's FDA-approved contraceptive pill Yasmin. YAZ contains ethinyl estradiol and drospirenone and is taken once a day for 24 days followed by four days of placebo to induce a menstrual period. Most oral contraceptives are taken for 21 consecutive days followed by seven days of placebos. FDA in November 2004 sent an approvable letter to Berlex for YAZ to be used as a contraceptive, and the company expected to receive final approval for sales of the pill by the end of 2005 (Kaiser Daily Women's Health Policy Report, 12/12/05). According to Reuters, YAZ has not yet been approved by FDA for use as a contraceptive (Reuters, 1/25). The company in a release said FDA has not requested additional clinical studies on the drug for use to treat PMDD, adding that it expects final approval by the end of the first quarter of 2006 (Schering release, 1/25). "It is a message from the FDA saying that they need more time," a Schering spokesperson said (Reuters, 1/25).


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