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QLT's Photofrin

This article was originally published in The Gray Sheet

Executive Summary

Quadra Logic Technologies submits application to market the light-activated drug as a palliative treatment for partially and totally obstructing cancers of the esophagus, the company says. The submission, which the firm claims would be the first ever filed for a drug-device combination for photodynamic therapy, consists of one new drug application and three premarket approval applications for lasers to activate the drug. The PMAs cover devices made by Coherent and Laserscope, as well as a "fiber optic owned by QLT." FDA's device center "will act in a consulting role" during premarket review of the applications by the agency's drug center, the firm reports
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