Axinn Obtains Favorable Decision in FDA Suit

Axinn secured a favorable outcome for client Alvogen Inc. in ViroPharma Inc’s case against the U.S. Food and Drug Administration regarding generic forms of the antibiotic Vancocin (vancomycin). The Axinn team assisted Alvogen Inc. in intervening on the side of the government in order to allow Alvogen to continue to market its generic vancomycin product under its approved Abbreviated New Drug Application.

Judge Huvelle’s Memorandum Opinion stated that “the FDA acted well within its discretion in denying three-year exclusivity to ViroPharma and in approving the ANDAs of intervenor-defendants.”