Schering AG's US affiliate, Berlex Inc., has received an approvable letter from the US Food and Drug Administration indicating that the premenstrual dysphoric disorder (PMDD) application for Yaz is approved. The FDA has not requested additional clinical studies.
Schering anticipates a decision on Yaz in the first quarter of 2006, states the company release.
Schering AG is a research-based pharmaceutical company. Its activities are focused on gynaecology, andrology, oncology, diagnostic imaging and specialised therapeutics for disabling diseases.