ViroPharma Suit Against FDA Over Generic Vancocin Tossed
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.
“We’ve been moving forward without counting on the revenue from Vancocin,” Broadbelt said in a phone interview.
ViroPharma has expanded its business in Europe and developed a focus on rare diseases, including hereditary angioedema, or HAE, an immune system deficiency, for which the company markets Cinryze in the U.S., Broadbelt said.
ViroPharma sued the FDA and the U.S. Department of Health and Human Services on April 13, three days after Akorn Inc. (AKRX) and Watson Pharmaceuticals Inc. (WPI) disclosed that they had won regulators’ approval to market generic forms of Vancocin.
ViroPharma sought injunctive relief and an order assigning it market exclusivity for Vancocin through Dec. 15, 2014.
Vancocin, which is taken orally, is known generically as vancomycin.
The case is ViroPharma Inc. v. Hamburg, 12-cv-00584, U.S. District Court, District of Columbia (Washington).
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