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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
Trade Name: CORLANOR
Date Designated: 03/23/2016
Orphan Designation: Treatment of pediatric patients (0 through 16 years of age) with dilated cardiomyopathy.
Orphan Designation Status: Designated/Approved
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.

Marketing approved:

1 Generic Name: ivabradine
Trade Name: CORLANOR
Marketing Approval Date: 04/22/2019
Approved Labeled Indication: Corlanor is indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate.
Exclusivity End Date: 04/22/2026 
Exclusivity Protected Indication* :  Corlanor is indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate.

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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