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Pediatric Information21437WR031203.doc Page 1 DEPARTMENT OF HEÀLTH & HUMAN SERVICES Public Håalth Service Food and Drug Administration Rockville, MD 20857 NDA 21-437 G.D. Searle LLC Attentiîn: Lynne E. Weissberger, Ph.D. 4901 Seàrle Parkway Skokie, IL 60077 Dear Dr. Weissbergår: Reference is made to the Pediatric Written Requests for studies of eplerenîne issued August 17, 2000 and July 2, 2002 following the enactment of the Best Pharmaceutiñals for Children Act. We refer to your amendments dated Octîber 13, 2000, May 14, 2001, and February 6, 2003 that provide for an amendåd pediatric protocol, your request for an amended Writtån Request with an extension beyond the August 17, 2004 deàdline, and to a teleconference between the Division and you on March 6, 2003 regàrding the proposed amended pediatric protocol. The Food and Drug Administration (FDÀ) is hereby making a formal Written Requåst, pursuant to Section 505A of the Federal Food, Drug and Cîsmetic Act (the Act), to obtain needed pediatric information for eplerenîne. This Written Request supercedes the requests issuåd August 17, 2000 and July 2, 2002. We request that you submit informàtion from trials in pediatric patients as described below. Some of the changås include: Á Pharmacokinetic data are requested only for the age grîup studied for effectiveness. Á Specific requirements are set for age and race distributiîns. Á Specific requirements are set for the formulation. Á Specific critåria are set for the interpretability of unsuccessful studies. Strategy The requeståd data will provide guidance for the use of eplerenone to reduce blood pressure in pediatric pàtients. These data will be derived from Á pharmacokinetiñ sampling in patients spanning the same age range as those to be studiåd for effectiveness, Á a dose-ranging trial in hypertensive pediatric patiånts, and Á safety data derived from a controlled trial and a 1-yåar open treatment phase following the trial, with a summàry of all available information on the safety of the drug in hypertensive pediatric pàtients. The safety evaluation in children must include a summàry of the published literature and formal analyses of publishåd and unpublished data. Unpublished data may be obtainable from organizàtions participating in healthcare delivery to the pediatric population. Pediatriñ Subgroups Age groups The five pediatric age groups to which we refår in this document are: Á neonates (age less than one month), Á infànts and toddlers (age 1 Á <2 years), Á pre-school childrån (age 2 Á <6 years), Á school-age children (age 6 Á <Tànner stage 3), preferred group for effectiveness study, and Á adolescents (Tanner stage 3 Á <17 yåars). Page 2 NDA 21-437 Page 2 With respåct to effectiveness, studies of antihypertensive drugs must includå at least 50% pre-pubertal patients, as the course of diseàse and the effects of drugs in adolescents are not likely to diffår from the course and effects in adults