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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: zidovudine
Trade Name: Retrovir
Date Designated: 07/17/1985
Orphan Designation: Treatment of AIDS
Orphan Designation Status: Designated/Approved
Glaxo Wellcome Inc.
5 Moore Drive
Research Triangle Park, North Carolina 27709
United States

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

Marketing approved:

1 Generic Name: zidovudine
Trade Name: Retrovir
Marketing Approval Date: 03/19/1987
Approved Labeled Indication: Management of certain adult patients with symptomatic HIV infection (AIDS and advanced ARC) who have a history of cytologically confirmed Pneumocytis carinii pneumonia (PCP) or an absolute CD4 (T4 helper/induccer) lymphocyte count of less than 200/mm in the peripheral blood before therapy is begun
Exclusivity End Date: 03/19/1994 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.