Last Friday, ViroPharma Incorporated (“ViroPharma”) filed a Complaint and a Motion for Temporary Restraining Order And/Or Preliminary Injunction in the U.S. District Court for the District of Columbia challenging FDA’s approval of three ANDAs for generic versions of ViroPharma’s VANCOCIN (vancomycin HCl) Capsules (Case No. 1:12-cv-00584-ESH). The lawsuit follows FDA’s April 9, 2012 response to a March 2006 petition for stay of action submitted by ViroPharma (and supplemented on several occasions since). FDA largely denied ViroPharma’s requests and approved ANDAs for generic VANCOCIN (see our previous post here). FDA determined that the Agency “has clear legal authority to recommend in vitro dissolution data to demonstrate generic vancomycin bioequivalence,” and that a December 2011 supplemental NDA FDA approved for VANCOCIN is not eligible for 3-year exclusivity because of the limitation on such exclusivity for a so-called “old antibiotic” like vancomycin set forth in FDC Act § 505(v) as added by Section 4 of the 2008 QI Act.
