25 January 2006 - FDA clarifies status of YAZTM PMDD application
Berlin, January 25, 2006 - Schering AG, Germany (FSE: SCH, NYSE: SHR) 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™ 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™ in the first quarter of 2006. About Berlex Berlex, a U.S. affiliate of Schering AG, is committed to addressing unmet medical needs through research and development in the areas of oncology, gastroenterology, women's health, diagnostics and neurology. Berlex also markets diagnostic imaging agents, innovative treatments in the areas of female health care and oncology, as well as specialized therapeutics for life-threatening and disabling diseases of the central nervous system and cardiovascular system. Berlex has business operations in New Jersey, California and Washington. For more information, please visit www.berlex.com 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 Berlex's plans and objectives to differ materially from those expressed or implied in the forward-looking statements. Berlex, Inc. 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. Berlex Contacts
Joanne Marion
973-487-2164
Rose Talarico
973-305-5302
