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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Rifapentine
Date Designated: 03/12/1996
Orphan Designation: Prophylactic treatment of Mycobacterium avium complex in patients with AIDS and a CD4+ count less than or equal to 75/mm3.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Hoechst Marion Roussel, Inc.
P.O. Box 9627
Mail Station: H3-M2516
Kansas City, Missouri 64134
United States

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

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.