The US Food and Drug Administration has extended its review of Clinuvel’s phototoxicity therapy, Scenesse (afamelanotide), by three months to allow the agency to complete its assessment of the drug’s benefit-risk profile.
The agency’s Division of Dermatology and Dental Products (DDDP) has changed the original Prescription Drug User Fee Act user fee goal date of 8 July to 6 October, and the date by which the FDA expects to comment on Scenesse’s product labeling and