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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  dexrazoxane hydrochloride
Date Designated:  08/19/2014
Orphan Designation:  Prevention of cardiomyopathy for chilren and adolescents 0 through 16 years of age treated with anthracyclines
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Satiscor, LLC
45 Marine Road
Boston, Massachusetts 02127
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.