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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
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* :  
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.