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FDA Grants Fast Track Designation to RYANODEX for Treatment of Exertional Heat Stroke; Fast Track Designation Highlights Serious, Unmet Medical Need that Exists for Patients with EHS

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“We are very encouraged by the FDA’s Fast Track designation, which is an acknowledgement of the seriousness of EHS and the current lack of a drug treatment. 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. 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,” said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
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Occurred on:
Feb 01, 2016
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Related Keywords Fast Track Designation, Fda, Ryanodex, Exertional Heat Stroke