
Dantrolene sodium
1-[[[5-(4-nitrophenyl)-2-furanyl]methylene]amino]-2,4-imidazolidinedione
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http://www.allfordrugs.com/2014/07/24/fda-approves-ryanodex-for
-the-treatment-of-malignant-hyperthermia/
FDA Approves Ryanodex for the Treatment of Malignant Hyperthermia
WOODCLIFF LAKE, N.J.(BUSINESS WIRE) July 23, 2014 —
Eagle Pharmaceuticals, Inc. (“Eagle” or “the Company”)
(Nasdaq:EGRX) today announced that 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.
read at
http://www.drugs.com/newdrugs/fda-approves-ryanodex-malignant-
hyperthermia-4058.html?utm_source=ddc&utm_medium=email&utm_
news+summary+-+July+23%2C+2014
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PATENTS, CAS NO ETC
http://www.allfordrugs.com/2014/07/24/fda-approves-ryanodex-
Filed under: 0rphan drug status, FDA 2014, Priority review Tagged: dantrolene sodium, Malignant Hyperthermia, orphan, Orphan Drug, PRIORITY, rayanodex
