• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
Generic Name: Atovaquone
Trade Name: Mepron
Date Designated: 08/14/1991
Orphan Designation: Prevention of Pneumocystis carinii pneumonia (PCP) in high-risk, HIV-infected patients defined by a history of one or more episodes of PCP and/or a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm3.
Orphan Designation Status: Designated/Approved
Glaxo Wellcome Research and Development
5 Moore Drive
PO Box 13398
Research Triangle Park, North Carolina 27709
United States

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

Marketing approved:

1 Generic Name: Atovaquone
Trade Name: Mepron
Marketing Approval Date: 01/05/1999
Approved Labeled Indication: Prevention of PCP in patients who are intolerant to trimethoprim-sulfamethoxazole.
Exclusivity End Date: 01/05/2006 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.