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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
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.

Marketing approved:

1 Generic Name: Rifabutin
Trade Name: Mycobutin
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* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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