ViroPharma Inc. (VPHM) Tuesday said the U.S. Food and Drug Administration has denied its petition related to its Vancocin capsules, with the agency approving three generic versions of the drug. Exton, Pennsylvania-based ViroPharma said it would seek an injunction to suspend FDA's approval of three generic versions of Vancocin.
The news sent ViroPharma shares plunging 20 percent on the Nasdaq.
Also on Tuesday, Akorn Inc. (AKRX) and Watson Pharmaceuticals Inc. (WPI) revealed that FDA approved each of theirs abbreviated new drug application for vancomycin hydrochloride USP capsules, the generic version of Vancocin. Vancocin is used for the treatment of Clostridium difficile-associated diarrhea, or CDAD, and also for enterocolitis, an inflammation of the colon and small intestine.
Both, Akorn and Watson said they have started shipping the generic version of Vancocin, which, according to IMS Health, generated sales of about $328 million in the US for twelve months ended December 31, 2011.
For the past five years, ViroPharma has been fighting with FDA over the agency's proposal to change the evaluation process and approval guidelines used to approve generic drugs.
ViroPharma believes that FDA has erred in interpreting its bioequivalence regulations in a manner that provides it with broad discretion to permit in vitro bioequivalence testing in the absence of a waiver of in vivo testing.
ViroPharma revealed that the FDA also refused its bid to extend the market exclusivity of Vancocin by an additional three years. The company had filed a supplemental new drug application for Vancocin. FDA said in order for an old antibiotic such as Vancocin to be eligible for a grant of exclusivity, it must be a significant new use or indication.
Additionally, ViroPharma also said it has been notified that the Federal Trade Commission is conducting an investigation whether it has engaged in unfair trade methods with respect to Vancocin. The company said it does not believe that it has engaged in unfair methods of competition and intends to cooperate with the investigation.
VPHM is currently trading at $22.85, down 20.13%, on a volume of 12.5 million shares, far above the three-month average volume of 1.1 million.
AKRX is currently trading on the Nasdaq at $11.88, up 1.71%, while Watson Pharmaceuticals is trading on the NYSE at $66.21, down 0.57%.
by RTT Staff Writer
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