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January 10, 2013

Brand name manufacturer's challenge of the FDA's approval of generic versions of Vancocin® denied

By Danielle H. Capilla, JD

A brand name drug manufacturer's motion for summary judgment challenging the FDA's approval of three generic versions of its antibiotic drug, Vancocin®, was denied (ViroPharma, Inc., v Hamburg, January 9, 2013, Huvelle, E). ViroPharma, Inc. (ViroPharma), the manufacturer of Vancocin®, alleged that the approval of three Abbreviated New Drug Applications (ANDAs), which permitted generic manufacturers to market generic versions of Vancocin, violated (1) ViroPharma's statutory rights to three years of marketing exclusivity; and (2) FDA regulations, because the ANDAs were based on inappropriate laboratory bioequivalence testing. The court found the FDA acted within its discretion to deny three years of exclusivity to VioPharma and in approving the three competing ANDAs.

Bioequivalence testing. VioPharma argued that the generic manufacturer's ANDAs were unallowably as based solely on in vitro (laboratory test-tube experiments) rather than in vivo (human) bioequivalence testing. However, as the court had ruled in earlier litigation in the case, the FDA acted within its authority to determine that for this drug, in vitro dissolution studies were the most accurate and sensitive to determine vancomycin bioequivalence. VioPharma presented no new arguments or evidence to show the FDA acted outside of its authority in its determination.

Exclusivity. VioPharma also argued it was entitled to an additional three years of statutory exclusivity to market Vancocin based on the QI Program Supplemental Funding Act of 2008 (P.L. 110-379), which allows the FDA to grant three years of exclusivity to "Old Antibiotics" on the basis of new clinical investigations. Based on this, VioPharma sought three additional years of exclusivity based on labeling changes. The FDA found that the labeling changes "related to and refined the already-approved indication for treatment" and denied the application. The court, which already denied VioPharma's statutory exclusivity claim in earlier litigation and opinions, found that VioPharma's new argument that denying it exclusivity would open the door for manufacturers to make labeling changes on their own accord unconvincing. VioPharma did not present the FDA with the necessary assessments and studies that would indicate it was submitting a new indication, dosing regimen or route of administration to the FDA for updating. The court found that it was not the "labeling changes" that were previously approved by the FDA, but it was the "conditions of use" for the drug that were previously approved and remained unchanged, therefore, there is no new clinical investigation to base an additional three years of exclusivity on.

The case number is: 12-0584 (ESH).

Christian G. Vergonis (Jones Day) for VioPharma Incorporated, plaintiff. Andrew E. Clark (U.S. Department of Justice) for Margaret A. Hamburg M.D., in her official capacity as Commissioner, Food and Drug Administration; Kathleen Sebelius, in her official capacity as Secretary, Department of Health and Human Services; and Department of Health and Human Services, defendants.

VioPharma Incorporated.

MainStory: TopStory GenericDrugNews FDCActNews DrugBiologicalNews HatchWaxmanNews LabelingNews DistrictofColumbiaNews

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