ANTIVIRAL DRUGS ADVISORY COMMITTEE
February 27, 2001
NDA 21-304, valganciclovir hydrochloride tablets, 450mg, Syntex (USA) LLC, proposed for treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).
Sponsor Presentation - Syntex (USA) LLC
The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
FDA Presentation doc pdf