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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: pralatrexate
Trade Name: Folotyn
Date Designated: 07/20/2006
Orphan Designation: Treatment of T-cell lymphoma
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: pralatrexate
Trade Name: Folotyn
Marketing Approval Date: 09/24/2009
Approved Labeled Indication: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma
Exclusivity End Date: 09/24/2016 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.