Summary
In reaction to the December 2008 FDA release of its Draft Guidance on Vancomycin Hydrochloride, ViroPharma announced Wed 18 Mar 2009 its submission of comments to the FDA. As the innovator company for VANCOCIN, a FDA Orange Book Rx Reference Listed Drug without any listed patents nor any listed exclusivities, ViroPharma's point of view directly against the FDA's Draft Guidance is expected. Analysis of the merits of these opposing viewpoints [FDA: in the Draft Guidance versus ViroPharma: in its comments] requires in-depth understanding of the underlying technical details within the context of the controlling laws and regulations.
Analysis
In addition to the FDA and ViroPharma, other players are actively involved in this situation. As expected, Mylan's point of view (as an ANDA Filer which continues to actively seek FDA approval of Mylan's generic version of VANCOCIN) is that the FDA Draft Guidance is correct and that ViroPharma's position is without substantial merit. The poor absorption of VANCOCIN's Active Product Ingredient, vancomycin hydrochloride, is a key factor in the ongoing dispute.
