• 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: 09/10/1990
Orphan Designation: Treatment of AIDS associated Pneumocystis Carinii Pneumonia.
Orphan Designation Status: Designated/Approved
Glaxo Wellcome Inc.
5 Moore Drive
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: 11/25/1992
Approved Labeled Indication: For the acute oral treatment of mild to moderate Pneumocystis carinii pneumonia in patients who are intolerant to trimethoprim-sulfamethoxazole.
Exclusivity End Date: 11/25/1999 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.