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Re: DewDiligence post# 199344

Monday, 02/01/2016 9:53:36 AM

Monday, February 01, 2016 9:53:36 AM

Post# of 257275
Ryanodex granted fast track.

"07:14 AM EST, 02/01/2016 (MT Newswires) -- Eagle Pharmaceuticals EGRX said the U.S. Food and Drug Administration has granted fast track designation to its RYANODEX injectable for the treatment of exertional heat stroke.

"EHS is a leading cause of death in young athletes and non-combat related fatalities in the military yet no drug products exist on the market today to treat this devastating and potentially fatal condition," said Scott Tarriff, President and Chief Executive Officer. "This Fast Track designation will enable us to work more closely with the FDA and expedite our program to make RYANODEX available to medical practitioners, and potentially expand the product's label to include EHS as an authorized second indication."

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