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# Shire ViroPharma Delayed Generic Vancocin: FTC
- URL: https://www.fdaweb.com/shire-viropharma-delayed-generic-vancocin-ftc/
- Published: 2017-02-07T12:00:00.000Z
- Updated: 2026-09-14T22:05:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137925

The Federal Trade Commission (FTC) says in a federal court complaint that Shire ViroPharma violated antitrust laws by submitting multiple petitions to FDA and filing court suits against the agency to delay FDA approval of generic Vancocin HCl capsules. The complaint [says](https://www.ftc.gov/news-events/press-releases/2017/02/ftc-charges-shire-viropharma-inc-abused-government-processes?ref=fdaweb.com) that due to the company’s actions, consumers and other purchasers paid hundreds of millions of dollars more for their medicines.

According to the FTC, ViroPharma submitted 43 filings with FDA and filed three lawsuits against the agency between 2006 and 2012\. “The number and frequency of ViroPharma’s petitioning at FDA are many multiples beyond that by any drug company related to any other drug,” the commission says in a statement. “ViroPharma knew that it was FDA’s practice to refrain from approving any generic applications until it resolved any pending relevant citizen petition filings. ViroPharma intended for its serial filings to delay the approval of generics, and thus competition and lower prices.”

The company started its filings, FTC says, after a 2006 FDA recommendation that companies seeking approval for generic Vancocin capsules could establish bioequivalency through test tube dissolution studies rather than by a clinical trial. The complaint says the company failed to provide any clinical data to support its arguments. And even after a panel of 16 independent scientific and medical experts considered ViroPharma’s arguments and unanimously recommended support for the FDA guidance for generic Vancocin capsules, the company continued to repeat its rejected arguments, FTC says.

The complaint asks for a court order permanently prohibiting ViroPharma from submitting repetitive and baseless filings with FDA and the courts, and from similar and related conduct, as well as any other necessary equitable relief, including restitution and disgorgement.