BioCentury
ARTICLE | Company News

KV appealing dismissal of suit against FDA

March 12, 2013 12:07 AM UTC

KV Pharmaceutical Co. (OCTQB:KVPHQ) filed a notice of appeal in the U.S. Court of Appeals for the District of Columbia Circuit of a lower court's dismissal of a suit from KV against FDA over the company's preterm birth drug Makena hydroxyprogesterone caproate. In September, a judge in the U.S. District Court for the District of Columbia dismissed the suit, under which KV was alleging that FDA's policy of non-enforcement for compounded hydroxyprogesterone caproate products violated KV's right to market exclusivity for Makena under the Orphan Drug Act (see BioCentury Extra, Sept. 6, 2012). ...