Skip to main content

Helsinn Integrative Care receive 510(K) FDA Clearance for Medical Device Xonrid® Gel

 

Clinical courses

 

Clinical courses

Helsinn Integrative Care, Helsinn’s business unit focused on evidence-based, non-pharmaceutical cancer supportive care products, announces that Xonrid® Gel, a topical gel for radiotherapy-induced dermatitis, already classified as a medical device in the EU, has received 510(K) FDA clearance in the US.

This now allows Xonrid® Gel to be marketed in the US for the management and relief of the burning and itching experienced by patients with radiation dermatitis. Riccardo Braglia, Helsinn Group Vice Chairman and CEO, commented: “Helsinn Integrative

Care aims to respond to the growing demand from patients for non-pharmaceutical approaches for the management of cancer symptoms solutions backed by robust, evidence-based data. We hope to be able to support both patients and healthcare providers to make informed choices about cancer management.

 

“Clearance from the FDA for Xonrid® Gel will allow wider access to cancer patients experiencing dermatitis as a painful side effect of radiation, and is a validation of our approach to this new and under-served market.”

<< Pharma News

Subscribe to PharmaTutor News Alerts by Email