Eagle Pharmaceuticals passes US FDA's approval for Ryanodex for treating malignant hyperthermia.
M2 PHARMA-July 24, 2014-Eagle Pharmaceuticals passes US FDA's approval for Ryanodex for treating malignant hyperthermia
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Pharmaceutical company Eagle Pharmaceuticals (NasdaqGM:EGRX) revealed on Wednesday that it has received approval from the US Food and Drug Administration (FDA) for Ryanodex (dantrolene sodium), which is used for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures.
Malignant hyperthermia is reportedly a condition that can be triggered when genetically susceptible individuals come in contact with certain inhaled (volatile) anesthetics or the muscle relaxant succinylcholine. These patients can experience tachycardia, elevated blood pressure, raised carbon dioxide levels, and very high body temperature levels.
Ryanodex (dantrolene sodium) is a novel formulation of the antidote for management of malignant hyperthermia (MH) and now provides a therapeutic loading dose of dantrolene sodium in a single vial. 250 mg of Ryanodex mixed with only 5 mL of sterile water and administered to the patient in less than one minute, said the company.
The company added that the US FDA had designated Ryanodex as an Orphan Drug in August 2013 and will decide over the next four to six weeks if it will grant the seven year Orphan Drug market exclusivity.
According to the company, it is the exclusive licensee of four US patents for Ryanodex, which will also represent its marketed first product.
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|Date:||Jul 24, 2014|
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