ViroPharma files supplement to vancocin petition for stay of action.

(From Chemical Business NewsBase - Press Release)

ViroPharma Inc filed a supplement to its petition for stay of action with the FDA regarding the bio-equivalence requirements for abbreviated new drug applications (ANDAs) that seek to copy Vancocin. The document sets forth legal arguments in support of ViroPharma's strong belief that the decision of the FDA's Office of Generic Drugs (OGD) to lower the bio-equivalence standards for generic copies of Vancocin violated numerous federal statutes and FDA's own regulations with the result that the new standard cannot, as a matter of law, be used in the review or approval of applications for generic versions of Vancocin. In …