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Photocure Announces U.S. FDA Approval of New Indications for Blue Light Cystoscopy
Feb. 16, 2018 08:41AM PST
Pharmaceutical InvestingPhotocure (OSE: PHO), announced today that the U.S. Food and Drug Administration approved its supplemental new drug application (sNDA) to extend the indication for Blue Light Cystoscopy with Cysview® to include Flexible Cystoscopes, which are used in the ongoing surveillance of patients with bladder cancer. This is the only combination of drug and device approved for the …
Photocure (OSE: PHO), announced today that the U.S. Food and Drug Administration approved its supplemental new drug application (sNDA) to extend the indication for Blue Light Cystoscopy with Cysview® to include Flexible Cystoscopes, which are used in the ongoing surveillance of patients with bladder cancer. This is the only combination of drug and device approved for the detection of bladder cancer.
As quoted in the press release:
“This approval is an important milestone for Photocure. With 1.2 million surveillance cystoscopies performed annually in the U.S., this represents a significant opportunity for the company and allows us to bring solutions to current clinical challenges,” said Kjetil Hestdal M.D. Ph.D., President & CEO. “The expanded label now allows repetitive use in the same patient which enables physicians to provide an improved continuum of care to their bladder cancer patients and should lead to reduced cost.”
