Here comes generic version; 20 percent off.
ViroPharma drops 20% after Vancocin generic approvals, FTC investigation
Theflyonthewall.comTheflyonthewall.com – 1 hour 11 minutes ago
Companies:
ViroPharma Inc.
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VPHM 28.61 0.00
08:37 EDT ViroPharma drops 20% after Vancocin generic approvals, FTC investigation..
source: the flyonthewall
"ViroPharma announces that the FDA has denied its citizen petition regarding bioequivalence and exclusivity for Vancocin capsules; FTC conducting investigation (VPHM) 28.61 : Co announced the FDA denied the citizen petition filed by ViroPharma on March 17, 2006 related to the FDA's proposed in vitro method for determining bioequivalence of abbreviated new drug applications referencing Vancocin (vancomycin hydrochloride, USP) Capsules. In the FDA's response to the citizen petition, the agency denied ViroPharma's citizen petition and also informed the company that a final guidance for vancomycin bioequivalence consistent with the FDA's citizen petition response is forthcoming. The FDA also informed ViroPharma in the same correspondence that the recent supplemental new drug application for Vancocin approved December 14, 2011 would not qualify for three additional years of exclusivity based on the agency's assertion that in order for an sNDA for an old antibiotic such as Vancocin to be eligible for a grant of exclusivity, it must be a significant new use or indication. FDA also indicated that it is approving three ANDA's for generic vancomycin capsules. ViroPharma intends to file a complaint in the United States District Court for the District of Columbia, seeking an injunction to set aside the FDA's approval of ANDA's for generic versions of Vancocin. In addition, the company has received a notification that the Federal Trade Commission is conducting an investigation into whether the company has engaged in unfair methods of competition with respect to Vancocin."
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