Eagle Pharmaceuticals Inc.'s (EGRX) injectable drug Ryanodex, indicated for the treatment of malignant hyperthermia, has won FDA approval. This is the second regulatory approval, which the company is receiving in less than a month.
Malignant hyperthermia is a potentially fatal, inherited disorder usually associated with the administration of certain general anesthetics and/or the drug succinylcholine.
Eagle Pharma noted that Ryanodex will be available to order through national and regional drug wholesalers in August with product shipping shortly after. Ryanodex has orphan drug status, which provides the company seven years of market exclusivity.
On July 2, 2014 Eagle Pharma received tentative approval for its patented, ready-to-dilute Bendamustine Hydrochloride Injection (EP-3101) for the treatment of Indolent B-cell non-Hodgkin lymphoma.
EGRX has thus far hit a low of $9.16 and a high of $16.44.
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