Recent regulatory news focused on a drug used to prepare patients for bone marrow and blood stem cell transplants and on a drug used to prevent rejection of a new heart.
In early October, the Food and Drug Administration approved a new drug application and granted priority review status to Busulfex (busulfan) Injection, a product of Orphan Medical, Inc., of Minneapolis. An FDA advisory committee is scheduled to review Busulfex in January 1999.
Busulfex is an intravenous form of busulfan intended for use in combination with other drugs or radiotherapy to prepare patients for marrow and stem cell transplants. Its formulation "provides a potential advancement to the current oral formulation by allowing accurate dosing," Orphan Medical said in a statement.
In other news, the European Commission has approved Roche's CellCept (mycophenolate mofetil) for the prevention of rejection in heart transplant patients. In the United States, CellCept was approved for the same indication in February, and it has been approved since 1995 to fight kidney rejection.
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