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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: vinCRIStine sulfate LIPOSOME injection
Trade Name: Marqibo
Date Designated: 01/08/2007
Orphan Designation: Treatment of acute lymphoblastic leukemia
Orphan Designation Status: Designated/Approved
Acrotech Biopharma LLC
279 Princeton Hightstown Road
East Windsor, New Jersey 08520
United States

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

Marketing approved:

1 Generic Name: vinCRIStine sulfate LIPOSOME injection
Trade Name: Marqibo
Marketing Approval Date: 08/09/2012
Approved Labeled Indication: Treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies.
Exclusivity End Date: 08/09/2019 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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