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ViroPharma Announces Approval of Modernized Labeling for Vancocin® (vancomycin hydrochloride, USP) Capsules
Date:12/14/2011

work further underscores the importance of such measures, but to date FDA has not indicated it will accede to the advice of its Advisory Committee experts.

Litigation Update

ViroPharma has two suits pending against FDA regarding Vancocin.  A Freedom of Information Act (FOIA) suit seeking the administrative record of FDA's development of in vitro dissolution as a bioequivalence method for generic vancomycin capsules is currently pending decision in federal district court.   ViroPharma also filed an Administrative Procedure Act (APA) suit alleging that FDA's in vitro bioequivalence method for generic vancomycin capsules is flawed under the APA. Oral arguments on the district court's procedural dismissal of this suit are currently scheduled for January 13, 2012 before the United States Court of Appeals for the District of Columbia Circuit.

About Vancocin® (vancomycin hydrochloride, USP) Capsules

Vancocin is indicated for the treatment of C. difficile-associated diarrhea (CDAD).  Vancocin is also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains).  Vancocin is contraindicated in patients who have experienced a hypersensitivity to vancomycin.  Vancocin must be given orally for treatment of staphylococcal enterocolitis and CDAD. Orally administered Vancocin is not effective for other types of infections.  Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of Vancocin for active CDAD.  Monitoring of serum concentrations may be appropriate in some instances. 

Nephrotoxicity has occurred following oral Vancocin therapy and can occur either during or after completion of therapy. The risk is increased in geriatric patients.  Monitor renal function.  Ototoxicity has occurred in patients receiving
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SOURCE ViroPharma Incorporated
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