Roche valganciclovir
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Company submitted an NDA Oct. 1 for the Cytovene (ganciclovir) pro-drug for treatment of cytomegalovirus retinitis in patients with AIDS. Phase III study results showed that two groups of patients taking either valganciclovir or Cytovene had equivalent rates of progression of CMV retinitis as measured by retinal photograph