Celsion Receives Positive FDA Guidance for its New Drug Application

Celsion Corporation

announced that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) that the requirements for non-clinical studies have been met for the New Drug Application of ThermoDox. The FDA has provided written guidance that the Company is not required to conduct any additional non-clinical pharmacology, safety pharmacology and general toxicology studies assuming the results of current studies are adequate. The results of these current studies will be reviewed at the time of NDA submission. This agreement takes advantage of an NDA application known as a 505(b)2 which allows a company to reference existing data regarding doxorubicin and other liposomal drugs currently approved by the FDA.