October 10—Shire plc announced today that its collaborative partner New River Pharmaceuticals Inc. has received an approvable letter from the U.S. Food and Drug Administration for NRP104 (lisdexamfetamine dimesylate), for the treatment of pediatric ADHD. According to the FDA's letter, marketing approval of NRP104 is contingent upon final scheduling by the U.S. Drug Enforcement Administration. No additional studies have been requested by the FDA as a condition for approval of NRP104. Shire and New River will continue dialog with FDA officials to agree upon a final trade name. Shire and New River Pharmaceuticals are preparing for a product launch (Medical News)