The Food and Drug Administration (FDA) has informed Photocure that the new drug application (NDA) for Hexvix for detection of non-invasive papillary bladder cancer may be approved pending approval of the PMA for the Karl Storz photodynamic diagnosis system and final agreements between Photocure and FDA on labeling, and post-marketing commitments. The photodynamic diagnosis system is the blue light cystoscopy system that will be used with Hexvix on the US market. Photocure expects the pending issues to be agreed with FDA within the first half year of 2010...
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