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Pediatric Licensing Status and the Availability of Suitable Formulations for New Medical Entities Approved in the United States Between 1998 and 2002

From the School of Pharmacy (Mr Balakrishnan, Ms Grieve, Ms Tordoff, Dr Norris), and the Dunedin School of Medicine (Dr Reith), University of Otago, Dunedin, New Zealand.

The availability of new medical entities for children in the United States was examined at the time of marketing approval and 3 years later. New medical entities approved in the United States in each of the years 1998 to 2002 were identified using the Center for Drug Evaluation and Research Web site. Each Physicians' Desk Reference published in the years 1998 to 2005 was examined to determine formulations and licensing information. For the 133 new medical entities licensed to be marketed in the period 1998 to 2002, the number licensed for children increased from 5 (4%) to 39 (29%) in the 3 years after registration. After 3 years' marketing, 79 (59%) drugs were in formulations suitable for children, and 27 (20%) of the new medical entities were licensed and had a suitable formulation for children. Incentives to improve access for children to medicines should focus more on demonstration of improved access.

Key Words: Pediatric licensing • new medical entities • formulations • off-label

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