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FDA Approves Ryanodex for the Treatment of Malignant Hyperthermia

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Dantrolene Tanaka et al.svg

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_

campaign=Today%27s+

news+summary+-+July+23%2C+2014

 

 

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PATENTS,  CAS NO ETC

http://www.allfordrugs.com/2014/07/24/fda-approves-ryanodex-

for-the-treatment-of-malignant-hyperthermia/


Filed under: 0rphan drug status, FDA 2014, Priority review Tagged: dantrolene sodium, Malignant Hyperthermia, orphan, Orphan Drug, PRIORITY, rayanodex

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