Ribavirin (Copegus®; Rebetol®; Ribasphere®; Vilona®,Virazole®, also generics from Sandoz, Teva, Warrick) is an anti-viral drug which is active against a number of DNA and RNA viruses. It is a member of the nucleoside antimetabolite drugs that interfere with duplication of viral genetic material. Though not effective against all viruses, ribavirin is remarkable as a small molecule for its wide range of activity, including important activities against influenzas, flaviviruses and agents of many viral hemorrhagic fevers.
Ribavirin is a pro-drug, activated by cellular kinases which change it into the 5' triphosphate nucleotide. In this form it interferes with aspects of RNA metabolism related to viral reproduction. A number of mechanisms have been proposed for this (see Mechanisms of Action, below) but none of these is proven. More than one mechanism may be active.
In the U.S. the oral (capsule or tablet) form of ribavirin is used in the treatment of hepatitis C, in combination with interferon drugs. The aerosol form is used to treat respiratory syncytial virus-related diseases in children. In Mexico, ribavirin ("ribavirina") has been sold for use against influenza.
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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
WL Issued to Youabian, IncFDA Tue, 17 Mar 2009 00:00:00 -0400
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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