FDA Approves Eagle Pharma's Rx for Rare Genetic Disorder

Ryanodex gets US FDA approval for treatment of malignant hyperthermia

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Eagle Pharmaceuticals, Inc., has announced that the US Food and Drug Administration approved its medication Ryanodex to treat an inherited and potentially deadly condition called malignant hyperthermia (MH).

MH is a life-threatening reaction to anesthetics or muscle relaxants used during surgery. The reaction can involve rapid heart rate, muscle rigidity, high body temperature, muscle breakdown and increased acid content.

"Tell your anesthesiologist about any reactions you've had in the past."

Ryanodex represents the first improvement in MH treatment in more than three decades. The medication is a reformulation of dantrolene sodium, the only antidote for MH.

"We are very pleased with today's approval of Ryanodex, which enables health care providers to better meet the needs of patients experiencing a life-threatening MH crisis," said Scot Tarriff, CEO of Eagle Pharmaceuticals, in a company press release.

According to Eagle Pharmaceuticals, Ryanodex will be available to order through drug wholesalers in August. The medication is expected to ship shortly thereafter.

Review Date: 
July 23, 2014
Last Updated:
July 24, 2014