Eagle Pharmaceuticals, Inc. today announced the U. S. Food and Drug Administration (FDA) has approved Ryanodex® (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures. MH is an inherited and potentially fatal disorder triggered by certain anesthesia agents in genetically susceptible individuals. FDA had designated Ryanodex as an Orphan Drug in August 2013. Eagle has been informed by the FDA that it will learn over the next four to six weeks if it has been granted the seven year Orphan Drug market exclusivity.
The Malignant Hyperthermia Association of the United States (MHAUS) is pleased to share this, and any new treatment options as they become available, with the heallthcare professionals and their patients whom we assist in order to effect a positive outcome when an unexpected MH event occurs.
"When a patient experiences malignant hyperthermia during surgery, it is a life‐threatening emergency requiring immediate treatment including the administration of the 'antidote' drug dantrolene sodium," said Henry Rosenberg, MD, CPE, a founder and President of the Malignant Hyperthermia Association of the United States (MHAUS). "The ability for healthcare professionals in hospitals and surgery centers to more quickly prepare and administer this new formulation of the antidote dantrolene sodium is expected to bring the crisis under control more rapidly and prevent severe complications from MH."
Eagle Pharmaceuticals, Inc.