By Kurt R. Karst –
In what might be the longest citizen petition response of all-time (87-pages!), FDA, on April 9, 2012, largely denied a March 17, 2006 petition for stay of action (here and here) (Docket No. FDA-2006-P-0007) submitted by ViroPharma Incorporated (“ViroPharma”) concerning the approval of ANDAs for generic versions of the company’s antibiotic drug, VANCOCIN (vancomycin HCl) Capsules (approved under NDA No. 050606). FDA also states in the petition response that the Agency approved three ANDAs for generic VANCOCIN, including one from Akorn, Inc. (represented by Hyman, Phelps & McNamara, P.C.).
ViroPharma supplemented the petition numerous times over the years, including a December 2011 submission claiming that changes to VANCOCIN’s labeling FDA approved on December 14, 2011 in an NDA Supplement should be eligible for a period of 3-year exclusivity that should prevent ANDA approvals until December 2014. FDA determined that the VANCOCIN approval is not eligible for 3-year exclusivity because of the limitation on such exclusivity for a so-called “old antibiotics” like vancomycin set forth in FDC Act § 505(v) as added by Section 4 of the 2008 QI Act. Specifically, FDA stated in the Agency’s decision that “the revision of the Vancocin label to incorporate clinical data that supports and refines labeling regarding already approved conditions of use, does not constitute approval for a condition of use that has not been ‘approved before the date of enactment’ within the meaning of [FDC Act § 505(v)(3)(B)]. Therefore, these labeling changes do not merit 3-year exclusivity under the limitation on such exclusivity for an Old Antibiotic subject to [FDC Act § 505(v)(3)].”
Given ViroPharma’s previous litigation concerning VANCOCIN (see, e.g., here and here), it came as no surprise when the company announced early on April 10, 2012 that it intended to file suit against FDA seeking an injunction to set aside the Agency’s ANDA approvals. As of this posting, we have not seen any court filings. We will update this post once the documents are available.
- See our April 16, 2012 post - The Other Shoe Drops: ViroPharma Sues FDA – Challenges Denial of 3-Year Exclusivity and ANDA Approvals