Photocure files supplemental New Drug Application with FDA for Blue Light Cystoscopy (BLC(TM)) with Cysview®
Oslo, Norway, August 16[th] Photocure ASA (OSE: PHO) announced today that it has filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) for BLC[(TM) ]with Cysview[®] for use during surveillance cystoscopy to detect recurrence of bladder cancer using a flexible cystoscope. The filing is a combination drug device application with the KARL STORZ D-LIGHT C PDD Flexible Videoscope System. The sNDA also supports the approval for repeated use of BLC with Cysview and to expand the indication include detection of carcinoma in situ (CIS). BLC with Cysview