ViroPharma Provides Update on Status of Citizen Petition Regarding Bioequivalence and Exclusivity for Vancocin Capsules

ViroPharma Incorporated

today announced the U.S. Food and Drug Administration denied the citizen petition (Docket # FDA-2006-P-0007) filed by ViroPharma on March 17, 2006 related to the FDA's proposed in vitro method for determining bioequivalence of abbreviated new drug applications (ANDAs) referencing Vancocin® (vancomycin hydrochloride, USP) Capsules. In the FDA's response to the citizen petition, the agency denied ViroPharma's citizen petition and also informed the company that a final guidance for vancomycin bioequivalence consistent with the FDA's citizen petition response is forthcoming. ViroPharma intends to file a complaint in the United States District Court for the District of Columbia, seeking an injunction to set aside the FDA's approval of ANDA's for generic versions of Vancocin. While the courts dismissed ViroPharma's prior lawsuit on the procedural basis of standing, the substance of the company's bioequivalence arguments and the arguments regarding Vancocin's eligibility for exclusivity have not been litigated before the Court. As it has since 2006, the company will actively pursue a legal remedy in these matters in order to ensure the safety of patients. ViroPharma's efforts to date have already helped make FDA's approval standards for generic vancomycin capsules more patient-protective. FDA's 2006 in vitro bioequivalence method did not protect patients from the risks of inactive ingredient differences, but after ViroPharma filed its petition FDA in 2008 determined that generic products would not be eligible for the in vitro method unless they have the same inactive ingredients in the same quantities as Vancocin. And in yesterday's petition response FDA further tightened the standards to require that generics use a particular grade of polyethylene glycol. ViroPharma believes that FDA is incorrect in interpreting its bioequivalence regulations in a manner that provides it with broad discretion to permit in vitro bioequivalence testing in the absence of a waiver of in vivo testing. ViroPharma believes that the FDA's position is not supported by its regulations, or by FDA's stated interpretation of those regulations at the time of their enactment.