PAXMAN supplements application for expanded FDA clearance in the USA
PAXMAN AB (publ) has supplemented the company’s premarket notification application to the US FDA for an expanded indication by responding to a request for additional information. The application seeks to expand use of the company’s scalp cooling to reduce the likelihood of chemotherapy-induced alopecia (CIA) in cancer patients with solid tumors.The additional information, that has been submitted to and received by the FDA, consists of an in-depth analysis of the clinical results provided as the basis for the expanded indication. “The clinical results for our expanded FDA application