BERLIN, Germany, January 25 /PRNewswire-FirstCall/ -- Schering AG, Germany announced today that its U.S. affiliate, Berlex, Inc., has received an approvable letter from the U.S. Food and Drug Administration (FDA) indicating that the premenstrual dysphoric disorder (PMDD) application for YAZ(TM) is approvable pending their review of recently submitted data and their satisfactory conclusion on its content. The FDA has not requested additional clinical studies.
Schering anticipates a decision on YAZ(TM) in the first quarter of 2006.
Schering AG is a research-based pharmaceutical company. Its activities are focused on four business areas: Gynecology&Andrology, Oncology, Diagnostic Imaging as well as Specialized Therapeutics for disabling diseases. As a global player with innovative products, Schering AG aims for leading positions in specialized markets worldwide. With in-house R&D and supported by an excellent global network of external partners, Schering AG is securing a promising product pipeline. Using new ideas, Schering AG aims to make a recognized contribution to medical progress and strives to improve the quality of life: making medicine work
This press release has been published by Corporate Communication of Schering AG, Berlin, Germany.
Your contacts at Corporate Communication:
Media Relations: Oliver Renner , T: +49-30-468-124-31, oliver.renner@schering.de
Investor Relations: Peter Vogt, T: +49-30-468-128-38, peter.vogt@schering.de
Pharma Communication: Astrid Kranz, T: +49-30-468-120-57, astrid.kranz@schering.de
Your contacts in the U.S.:
Media Relations: Kim Schillace, T:+1-973-305-5258, kimberly_schillace@berlex.com
Investor Relations: Joanne Marion, T: +1-973-487-2164, joanne_marion@berlex.com
Find additional information at: www.schering.de/eng
Certain statements in this press release that are neither reported financial results nor other historical information are forward-looking statements, including but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results and Schering AG’s plans and objectives to differ materially from those expressed or implied in the forward-looking statements. Certain factors that may cause such differences are discussed in our Form 20-F and Form 6-K reports filed with the U.S. Securities and Exchange Commission. Schering AG undertakes no obligation to update publicly or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.
Schering AG
CONTACT: Corporate Communication: Media Relations: Oliver Renner , Tel:+49-30-468-124-31, oliver.renner@schering.de, Investor Relations: PeterVogt, Tel: +49-30-468-128-38, peter.vogt@schering.de, Pharma Communication:Astrid Kranz, Tel: +49-30-468-120-57, astrid.kranz@schering.de, in theU.S.: Media Relations: Kim Schillace, Tel: +1-973-305-5258,kimberly_schillace@berlex.com, Investor Relations: Joanne Marion, Tel:+1-973-487-2164, joanne_marion@berlex.com
