Its previous plan was for submission in 2006.
The date for filing has already been pushed back once, when Schering in July announced it would no longer file for approval in 2005.
Schering and US partner TAP Pharmaceutical Products Inc had to stop so-called extension studies which evaluated the long-term usage of the drug.
The extension studies -- which would have extended patients total therapy duration for up to four years -- will be amended after some patients experienced adverse effects in the form of endometrial changes. Schering said these were reversible in most patients after stopping therapy, but this resulted in additional invasive procedures.
Schering has completed regular Phase II and Phase III trials, based on which it believes the drug is a promising therapy for women who suffer from uterine fibroids, and whose current options remain invasive procedures.
Uterine fibroids are benign smooth muscle tumours of the uterus, and may cause irregular menstruation.
ragnhild.kjetland@afxnews.com
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