The Food and Drug Administration has approved Eagle Pharmaceuticals' injectable dantrolene sodium suspension Ryanodex for treatment of malignant hyperthermia.
The approval comes after the FDA granted Ryanodex priority review status in March 2014.
The singe-use vial allows healthcare professionals to prepare and deliver dantrolene sodium, the only antidote for malignant hyperthermia — a rare genetic condition — much more efficiently than other products currently on the market and can be administered in less than one minute by a single healthcare professional, according to Eagle.
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The approval comes after the FDA granted Ryanodex priority review status in March 2014.
The singe-use vial allows healthcare professionals to prepare and deliver dantrolene sodium, the only antidote for malignant hyperthermia — a rare genetic condition — much more efficiently than other products currently on the market and can be administered in less than one minute by a single healthcare professional, according to Eagle.
More articles on accreditation:
Paper-based record keeping could affect patient safety, study finds
AAAHC celebrates 35 years
Emergency drill toolkit