Category: Citizen Petitions

  • Biovail Corporation (Canada) filed suit yesterday in the U.S. District Court for the District of Columbia against the U.S. Food and Drug Administration.  Biovail's complaint and motion for a temporary restraining order and preliminary injunction request the court to compel FDA action on Biovail's citizen petition submitted in December 2005 relating to the criteria used…

  • The FDA recently posted ViroPharma, Inc.'s scientific supplement to its citizen petition asking FDA to stay approval of generic Vancocin (vancomycin hydrochloride).  Vancocin is ViroPharma's orally administered tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis that is approved for treatment of colitis caused by susceptible bacteria.  There are no unexpired patents or other exclusivities available for…