ARTICLE | Company News

Photocure gives Hexvix update

December 31, 2009 10:48 PM UTC

Photocure ASA (OSE:PHO) said FDA may approve an NDA for Hexvix to detect non-invasive papillary bladder cancer, pending the approval of a PMA for a blue light cystoscopy system from Karl Storz GmbH & Co. (Tuttlingen, Germany) that would be used with Hexvix. Photocure said the approval of Hexvix is also contingent upon final agreements with FDA on labeling and postmarketing commitments. The company expects the pending issues to be resolved during 1H10. This month, FDA's Oncologic Drugs Advisory Committee voted 9-8 that Hexvix demonstrated a favorable benefit-risk profile. ...