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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: mavacamten
Trade Name: Camzyos
Date Designated: 04/27/2016
Orphan Designation: Treatment of symptomatic hypertrophic cardiomyopathy
Orphan Designation Status: Designated/Approved
MyoKardia, Inc. (A Wholly-Owned Subsidiary of Bristol Myers Squibb)
1000 Sierra Point Parkway
Brisbane, California 94005
United States

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

Marketing approved:

1 Generic Name: mavacamten
Trade Name: Camzyos
Marketing Approval Date: 04/28/2022
Approved Labeled Indication: Treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms
Exclusivity End Date: 04/28/2029 
Exclusivity Protected Indication* :  Treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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