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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Trimetrexate glucuronate
Trade Name: Neutrexin
Date Designated: 05/15/1986
Orphan Designation: Treatment of Pneumocystis carinii pneumonia in AIDS patients.
Orphan Designation Status: Designated/Approved
Medimmune Oncology, Inc.
One Tower Bridge
100 Front Street, Suite 400
West Conshohocken, Pennsylvania 19428
United States

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

Marketing approved:

1 Generic Name: Trimetrexate glucuronate
Trade Name: Neutrexin
Marketing Approval Date: 12/17/1993
Approved Labeled Indication: Concurrent leucovorin administration as an alternative therapy for the treatment of moderate to severe PCP in immunocompromised patients who are intolerant of, or are refractory to, trimethoprim sulfamethoxazole.
Exclusivity End Date: 12/17/2000 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.