PhotoCure - US New Drug Application approval expected for Metvix
Oslo, Norway, 17 June 2004.
The US Food and Drug Administration (FDA) officially informed PhotoCure that it intends to finish its review of Metvix® (methyl aminolevulinate), for the treatment of pre-cancerous lesions (actinic keratosis, AK), no later than July 27, 2004.
PhotoCure's first New Drug Application was submitted for Metvix for the treatment of actinic keratosis and is previously deemed approvable by the FDA. Prior to approval of Metvix, a cream that works in conjunction with the light source CureLight, the FDA requested a safety update on the Metvix product. This safety update was submitted to the FDA in May 2004. The FDA and PhotoCure have previously agreed on labelling for the Metvix product. Therefore, PhotoCure anticipates that final approval of Metvix will be issued by end of July 2004.