Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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: Megestrol acetate
Trade Name: Megace
Date Designated: 04/13/1988
Orphan Designation: Treatment of patients with anorexia, cachexia, or significant weight loss (=/>10% of baseline body weight) and confirmed diagnosis of AIDS.
Orphan Designation Status: Designated/Approved
Bristol-Myers Squibb Pharmaceutical Research Institute
2400 West Lloyd Expressway
Evansville, Indiana 47721
United States

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

Marketing approved:

1 Generic Name: Megestrol acetate
Trade Name: Megace
Marketing Approval Date: 09/10/1993
Approved Labeled Indication: Treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immune deficiency syndrome.
Exclusivity End Date: 09/10/2000 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-