FDA Updates Status of Its Response to Zocor Citizen Petitions

The FDA recently published a letter to attorneys representing generic drug companies who filed citizen petitions relating to their ANDAs for generic Zocor.

The three-page letter essentially ties up some loose ends that remained after the District of Columbia's April 30, 2006 decision holding that it was unlawful for the FDA to deny IVAX and Ranbaxy's citizen petitions to relist in the Orange Book two Merck patents covering Zocor.  While the FDA has appealed that decision to the Court of Appeals for the District of Columbia, and the appeal has been granted expedited review, in the meantime the FDA relisted the two Merck patents and granted 180 day market exclusivity to the first ANDA filers, IVAX and Ranbaxy.

IVAX, a division of Teva, and Ranbaxy launched their generic Zocor products last month when Merck's last patent on Zocor expired and they were granted final approval by the FDA.