ViroPharma Incorporated Suit Against FDA Over Generic Vancocin Tossed

Published: Jan 10, 2013

ViroPharma Inc. (VPHM)’s lawsuit against the U.S. Food and Drug Administration over generic forms of its antibiotic Vancocin was dismissed by a federal judge. The company failed to produce new evidence following rejection in April of its request for a court order to block FDA approval of three generic versions of Vancocin, U.S. District Judge Ellen Segal Huvelle in Washington said today in her ruling. “ViroPharma all but admits that it has presented no substantially new arguments, but rather relies on additional elaboration, none of which persuades the court to reverse itself,” Huvelle said. Huvelle upheld the FDA’s rejection of ViroPharma’s request for three years of market exclusivity for Vancocin on the strength of a labeling change. The new label pertained only to previously approved conditions of use and thus “was excluded from exclusivity,” Huvelle said. Vancocin, which ViroPharma markets for Clostridium difficile and other gastrointestinal infections, accounted for about $289 million in sales in 2011, about half of the drugmaker’s revenue. Kristina Broadbelt, a spokeswoman for the Exton, Pennsylvania-based company, said Huvelle’s decision wasn’t a surprise and that ViroPharma hasn’t decided whether to appeal it.

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