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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: sonrotoclax
Trade Name: Beqalzi
Date Designated: 12/21/2023
Orphan Designation: Treatment of Mantle Cell Lymphoma
Orphan Designation Status: Designated/Approved
BeOne Medicines USA, Inc.
311 Pennington-Rocky Hill Rd., Bldg 51-Ste 1358
Pennington, New Jersey 08534
United States

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

Marketing approved:

1 Generic Name: sonrotoclax
Trade Name: Beqalzi
Marketing Approval Date: 05/13/2026
Approved Labeled Indication: treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton¿s tyrosine kinase (BTK) inhibitor
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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