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March 20, 2014
08:02 EDTEGRXEagle Pharmaceuticals says FDA acceptsa NDA for Ryanodex
Eagle Pharmaceuticals announced that the United States Food and Drug Administration has accepted the company’s New Drug Application for Ryanodex and granted a priority review classification. The PDUFA date is July 22. In January 2014, Eagle filed its NDA with the FDA for the treatment of malignant hyperthermia. In February 2014, the FDA conditionally accepted Eagle’s trade name Ryanodex. Ryanodex has previously been granted Orphan Drug designation and Eagle currently owns three U.S. patents covering the product. Eagle intends to commercialize Ryanodex after approval and will retain exclusive marketing rights in the U.S.
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