ViroPharma 8-K 2012
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of Earliest Event Reported): April 9, 2012
(Exact Name of Registrant as Specified in its Charter)
(Registrants Telephone Number, Including Area Code)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Item 8.01. Other Events.
ViroPharma Incorporated (the Company) today announced that on April 9, 2012, the U.S. Food and Drug Administration (FDA) denied the Citizens Petition (Docket # FDA-2006-P-0007) filed by ViroPharma on March 17, 2006 related to the FDAs proposed in-vitro method for determining bioequivalence of abbreviated new drug applications (ANDAs) of Vancocin® (vancomycin hydrochloride, USP) Capsules. In the FDAs response to the citizens petition, the agency dismissed all scientific and legal questions raised by ViroPharma and also informed the company that a final guidance for vancomycin bioequivalence consistent with the FDAs citizen petition response is forthcoming. FDA also indicated that it is approving three ANDAs for generic vancomycin capsules.
The FDA also informed ViroPharma in the same correspondence that the recent sNDA for Vancocin from December 14, 2011 would not qualify for three additional years of exclusivity based on the agencys narrow interpretation of the statutory authority to require a significant new usage or new indications for, an old antibiotic (such as Vancocin) in order for a sNDA to be eligible for a grant of exclusivity.
ViroPharma intends to file a complaint in the United States District Court for the District of Columbia, seeking an injunction to enjoin the FDAs approval of ANDAs 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. The existence of an investigation does not indicate that the FTC has concluded that ViroPharma has violated the law and the company does not believe that it has engaged in unfair methods of competition with respect to Vancocin. The Company intends to cooperate with the FTC investigation.
The full text of a press release issued by the Company in connection with the announcement is set forth as Exhibit 99.1 attached hereto.
Item 9.01 Financial Statements and Exhibits.
The following exhibits are attached to this Form 8-K:
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Index of Exhibits