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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: copanlisib
Date Designated: 05/03/2021
Orphan Designation: Treatment of patients with Lymphoplasmacytoid lymphoma/ Waldenström macroglobulinemia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Bayer HealthCare Pharmaceuticals Inc.
100 Bayer Blvd
P.O.Box 915
Whippany, New Jersey 07981-0915
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.
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