PhotoCure - FDA Review of Metvix® for the treatment of skin cancer
Oslo, Norway, 3 December 2004 The US Food and Drug Administration (FDA) has reviewed PhotoCure's amendment, submitted in June 2004, to the marketing application (NDA) for Metvix® (methyl aminolevulinate) for the treatment of skin cancer (Basal Cell Carcinoma). FDA concludes that the current data submitted was insufficient for approval of the proposed indication. PhotoCure is now evaluating the requirements set out by FDA. These requirements include further clincal phase III studies and may take up to 2 years. The alternatives will be discussed with FDA. The FDA has previously
