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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: ivabradine
Date Designated: 07/09/2018
Orphan Designation: Treatment of post-cardiac transplant heart dysfunction
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 07/22/2019
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Amgen, Inc.,
1 Amgen Center Drive
Mail Stop 27-2-D
Thousand Oaks, California 91320
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.