US WorldMeds’s improved reconstitution product is expected to meet all current FDA approved release specifications. The company plans to file a submission in 2008 to obtain FDA approval of its dantrolene sodium for injection with improved reconstitution. Introduction of this fast reconstituted dantrolene sodium for injection is expected to represent an advancement in the pharmacotherapy of patients experiencing malignant hyperthermia during surgery.
Dantrolene sodium for injection is indicated, along with appropriate supportive measures, for the management of fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. It also is indicated preoperatively and sometimes postoperatively in individuals judged to be malignant hyperthermia susceptible.