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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 monoclonal antibody (immunoglobulin gamma-1 with kappa light chains, IgG1kappa) directed against human soluble cytokine interferon beta.
Date Designated: 11/05/2020
Orphan Designation: Treatment of dermatomyositis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Pfizer Inc.
66 Hudson Boulevard East
New York, New York 10001
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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