The U.S. Food and Drug Administration (FDA) has accepted for review Indevus' New Drug Application (NDA) for Sanctura XR (trospium choloride), the once-daily formulation of Sanctura, for the treatment of overactive bladder (OAB). The FDA Prescription Drug User Fee Act (PDUFA) target action date for Sanctura XR is August 13, 2007. The NDA was submitted to the FDA by the company on October 12, 2006.
The NDA includes the results of the Company's Phase III clinical program as well as the results of additional Phase I and Phase II studies. The previous NDA for Sanctura is also referenced for supportive data.
In addition to this clinical database, over 700,000 prescriptions for Sanctura have been written since the launch of the product in August 2004. Indevus co-promotes Sanctura with its partner, Esprit Pharma, which will also market Sanctura XR upon approval in the United States. Indevus licensed trospium chloride from Madaus GmbH, which markets the product for overactive bladder in multiple countries outside the United States.
Subscribe via RSS
