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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Alendronate disodium
Date Designated: 02/13/2001
Orphan Designation: Treatment of the bone manifestations of Gaucher disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Richard J. Wenstrup, M.D.
Division of Human Genetics
Children's Hospital Research Foundation
Cincinnati, Ohio 45229
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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