The US health regulator on Wednesday approved Johnson & Johnson unit Actelion Pharmaceuticals' injection for severe frostbite in adults, making it the first treatment for the condition to reduce the risk of amputation.
The treatment will be sold under the brand name Aurlumyn.
The company did not immediately respond to a request for details on pricing and availability.
Iloprost, the active ingredient in Aurlumyn, opens blood vessels and prevents blood from clotting.
Frostbite can occur in several stages. Mild frostbite does not require medical intervention and does not cause permanent skin damage, while severe frostbite, when both the skin and underlying tissue are frozen and blood flow is stopped, sometimes requires amputation.
Iloprost was originally approved in 2004 for the treatment of pulmonary arterial hypertension.