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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 Jan. 1, 2013, to the present.
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