Cytovene-IV Shortage - additional information

2/15/2002

The FDA Safety Information and Adverse Event Reporting Program - Healthcare professionals are advised of a critical shortage of Cytovene-IV, indicated for the treatment or prevention of cytomegalovirus (CMV) disease.

This shortage in supply is expected to last through the second quarter of 2002. Roche Laboratories urges physicians to explore alternative treatment therapies or management strategies for their patients. This temporary situation affects only the IV formulation of Cytovene, and not the oral formulation of Cytovene (ganciclovir capsules).

Please see the MedWatch Safety alert at

http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#cytove

for details, including a link to a copy of the letter from Roche Laboratories.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration