FDA pediatric study requests
Executive Summary
Agency issues written request for pediatric studies for Hoechst Marion Roussel's Priftin (rifapentine), Roche's Versed (midazolam) injection, Johnson & Johnson's Motrin (ibuprofen suspension) and Whitehall-Robin's Advil (ibuprofen suspension), following issuance of "Qualifying for Pediatric Exclusivity" guidance June 29