Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") EGRX today
confirmed that the U.S. Food and Drug Administration (FDA) has granted seven
years of market exclusivity in the U.S. to Ryanodex^® (dantrolene sodium) for
Injectable Suspension for the treatment of malignant hyperthermia (MH).
Ryanodex was designated an orphan drug in August 2013 and was approved by the
FDA in July 2014 for this indication.
"We are very pleased that the anticipated market exclusivity for this
important orphan drug has been formally granted," said Scott Tarriff,
President and Chief Executive Officer. "The response to Ryanodex has been
positive since its launch late last August, and we look forward to further
market penetration going forward."
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