NEW YORK (AP) — Shire PLC said Tuesday the FDA asked the company for more information on developing attention-deficit hyperactivity disorder drug Intuniv, but did not identify safety concerns or ask for more studies. The move comes after labeling discussion with the agency did not result in a scheduled regulatory date. Shire said it will work with the FDA on labeling language over the next four to eight weeks. The application for Intuniv was resubmitted to the FDA earlier this year as a treatment for ADHD in children and adolescents. The agency responded to the company’s previous application in 2007 with a series of questions. U.K.-based Shire also makes the ADHD drug Adderall.
