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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: pentostatin for injection
Trade Name: Nipent
Date Designated: 09/10/1987
Orphan Designation: Treatment of hairy cell leukemia
Orphan Designation Status: Designated/Approved
SuperGen, Inc.
4140 Dublin Blvd.
Suite 200
Dublin, California 94568
United States

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

Marketing approved:

1 Generic Name: pentostatin for injection
Trade Name: Nipent
Marketing Approval Date: 10/11/1991
Approved Labeled Indication: Single agent treatment for adult patients with alpha-interferon-refractory hairy cell leukemia.
Exclusivity End Date: 10/11/1998 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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