Schering AG, Germany announced that the US (FDA) has extended its New Drug Application (NDA) review goal date for the Company's low dose version of the oral contraceptive, Yasmin.
According to the US FDA's written notification to Berlex Inc, the US affiliate of Schering AG, the extension "will provide time for a full review" of the application. Schering is confident of a 2005 launch and will continue to work closely with the FDA to assist in the completion of the NDA review, a company release said.
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.