A Taste of Wellness for Savoury and Snacks
Givaudan
A group of advisors to the US Food and Drug Administration (FDA) will meet on January 24 to provide recommendations to the agency about possible new labeling for Wyeth-Ayerst's Rapamune oral solution and tablets.
Rapamune is already approved for prevention of organ rejection in renal transplant patients. The current US labeling states that the drug is to be used in a regimen with cyclosporine and corticosteroids, the FDA said in announcing the meeting.
The Immunosuppressive Drugs Subcommittee of the Antiviral Drugs Advisory Committee will discuss whether cyclosporine can be eliminated from the immunosuppressive regimen two to four months after transplantation under certain conditions, the agency said.
Wyeth-Ayerst is a division of American Home Products, which recently predicted that annual sales of Rapamune could top $300 million within 3 to 5 years.