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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Rifabutin
Trade Name:  Mycobutin
Date Designated:  12/18/1989
Orphan Designation:  Prevention of disseminated Mycobacterium avium complex disease in patients with advanced HIV infection.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  12/23/1992 
Approved Labeled Indication:  Prevention of disseminated Mycobacterium avium complex disease in patients with advanced HIV infections.
Exclusivity End Date:    12/23/1999 
Exclusivity Protected Indication* :  
Adria Laboratories, Inc.
P.O. Box 16529
Columbus, Ohio 43216
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.
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