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PhotoCure Metvix approval

Executive Summary

FDA will finish reviewing the Metvix (methyl amniolevulinate) NDA for actinic keratoses no later than July 27, PhotoCure says. An FDA advisory committee voted against approval of the phototherapy for the first-line treatment of basal cell carcinoma (1"The Pink Sheet" Sept. 15, 2003, p. 20). The NDA was later deemed "approvable," and PhotoCure submitted a safety update...

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