Valganciclovir hydrochloride (Valcyte®) is an antiviral medication used to treat cytomegalovirus infections. As the L-valyl ester of ganciclovir, it is actually a prodrug for ganciclovir. After oral administration, it is rapidly converted to ganciclovir by intestinal and hepatic esterases.
Administration
Orally, available in 450 mg pink tablets. Dosing is calculated to provide appropriate doses of ganciclovir; 900 mg of valganciclovir orally every 12 hours is equivalent to 5 mg per kilogram of body weight of intravenous ganciclovir, also every 12 hours.
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CFDA: FDA Latest Computer Systems Warning LettersWL Issued to Amrex Zetron IncFDA Tue, 14 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Amrex Zetron Inc on 14 Apr 2009 by Los Angeles District Office
WL Issued to Coast Institutional Review BoardFDA Tue, 14 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Coast Institutional Review Board on 14 Apr 2009 by Center for Drug Evaluation and Research
WL Issued to Branitz, Bruce, MDFDA Thu, 09 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Branitz, Bruce, MD on 09 Apr 2009 by Center for Drug Evaluation and Research
WL Issued to Cote, Charles J., MDFDA Mon, 02 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Cote, Charles J., MD on 02 Mar 2009 by Center for Drug Evaluation and Research
WL Issued to Genzyme CorporationFDA Fri, 27 Feb 2009 00:00:00 -0400
FDA Warning Letter Issued to Genzyme Corporation on 27 Feb 2009 by New England District Office
WL Issued to Hammill Manufacturing CompanyFDA Tue, 06 Jan 2009 00:00:00 -0400
FDA Warning Letter Issued to Hammill Manufacturing Company on 06 Jan 2009 by Cincinnati District Office
CFDA: FDA Latest Drug GCP Warning LettersWL Issued to Coast Institutional Review BoardFDA Tue, 14 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Coast Institutional Review Board on 14 Apr 2009 by Center for Drug Evaluation and Research
WL Issued to Branitz, Bruce, MDFDA Thu, 09 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Branitz, Bruce, MD on 09 Apr 2009 by Center for Drug Evaluation and Research
WL Issued to Bukowski, Ronald M, MDFDA Mon, 30 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Bukowski, Ronald M, MD on 30 Mar 2009 by Center for Drug Evaluation and Research
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FDA Warning Letter Issued to Youabian, Inc on 17 Mar 2009 by Los Angeles District Office
WL Issued to Provena St. Joseph's Medical Center IRBFDA Thu, 12 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Provena St. Joseph's Medical Center IRB on 12 Mar 2009 by Center for Biologics Evaluation and Research
WL Issued to Paulson, Daniel M., MDFDA Wed, 11 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Paulson, Daniel M., MD on 11 Mar 2009 by Center for Drug Evaluation and Research
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