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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  recombinant humanized IgG1-based monoclonal antibody which binds to human latent myostatin in a pH dependent manner
Date Designated:  12/07/2021
Orphan Designation:  Treatment of spinal muscular atrophy
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Genentech Inc.
1 DNA Way
South San Francisco, California 94080-4990
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.