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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: dantrolene sodium suspension for injection
Trade Name: RYANODEX
Date Designated: 08/16/2013
Orphan Designation: Treatment of malignant hyperthermia syndrome
Orphan Designation Status: Designated/Approved
Eagle Pharmaceuticals, Inc.
50 Tice Blvd
Suite 315
Woodcliff Lake, New Jersey 07677
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: dantrolene sodium suspension for injection
Trade Name: RYANODEX
Marketing Approval Date: 07/22/2014
Approved Labeled Indication: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures and for the prevention of malignant hyperthermia in patients at high risk.
Exclusivity End Date: 07/22/2021 
Exclusivity Protected Indication* :  Treatment of malignant hyperthermia in conjunction with appropriate supportive measures and for the prevention of malignant hyperthermia in patients at high risk.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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